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Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VR
In Commercial Distribution
- 00851362008094 ()
- Air-conduction hearing aid, behind-the-ear
Wesper Lab (āthe deviceā) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional.
Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (āthe appā), which resides on the patientās personal mobile device, relaying sleep data wirelessly to a secure remote storage location (āthe cloudā) for subsequent analysis by a healthcare professional.
The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient.
The deviceās BLE ports connect to the following:
1. Abdominal patch
2. Thoracic patch
3. Pulse oximeter
Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter.
This Device Identification is for a kit that is shipped without a charger.
Tatch Inc.
WSWW-RE-K-N-V02-BLO
In Commercial Distribution
- 00860007837029 ()
- Polysomnograph
The INVU by Nuvoā¢ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVUā¢ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA).
The INVU by Nuvoā¢ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Bandā¢) that connects wirelessly to the INVUā¢ App installed on the pregnant personās mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant personās medical supervisor. The INVUā¢ App installed on the pregnant personās smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVUā¢ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Proā¢ web application.
Nuvo Group Usa, Inc.
NV-INVU-0001
In Commercial Distribution
- 07290018250044 ()
INVU 3200
- Foetal/maternal prenatal monitor
Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT2S
In Commercial Distribution
- 00851362008551 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT1R
In Commercial Distribution
- 00851362008452 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT2R
In Commercial Distribution
- 00851362008353 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT1S
In Commercial Distribution
- 00851362008346 ()
- Air-conduction hearing aid, behind-the-ear
ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.
The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer.
The subject device, ClariCT.AI, added a new module (named AI Marketplace Integration module) to the original cleared device (K183460) to enable installation on the AI Marketplace system. The module integrates the Denoising Processor of original device into the AI Marketplace system. ClariCT.AI, consists only of the AI Marketplace Integration Module and the Denoising Processor, can be installed in the AI Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.
An AI Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based AI platform service that connects end users (e.g. hospitals, imaging centers) and AI medical imaging applications developed by third parties. These AI Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party AI applications. With the newly added module, ClariCT.AI will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interface.
ClariPI Inc.
1.3.3
In Commercial Distribution
- 08800046800136 ()
- Radiology DICOM image processing application software
E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display);
WELCH ALLYN, INC.
901134
In Commercial Distribution
- 00732094265057 ()
ESWKST-DAA-AXXXX
- Patient health record information system application software
ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution
- B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&
- Electrocardiography telemetric monitoring system