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Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
Philips Medical Systems Nederland B.V.
3.x
In Commercial Distribution
- 00884838085640 ()
760001
- Microscope slide digital imaging scanner IVD
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
9.x
Not in Commercial Distribution
- 00884838075894 ()
- Radiology DICOM image processing application software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936889 ()
- Patient general health self-management software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936872 ()
- Patient general health self-management software
No Description
Budget Hearing Aids, LLC
Atom X
In Commercial Distribution
- 00850065060880 ()
- Air-conduction hearing aid, canal
No Description
Bausch & Lomb GmbH
E3305 X
In Commercial Distribution
- 04058935012045 ()
- Corneal scissors, reusable
No Description
Bausch & Lomb GmbH
E3839 X
In Commercial Distribution
- 04058935011659 ()
- Suturing needle holder, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXD2040
Not in Commercial Distribution
- 00851913006395 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXD2020
Not in Commercial Distribution
- 00851913006388 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXB50100
In Commercial Distribution
- 00851913006326 ()
- Transcutaneous electrical stimulation electrode, reusable
- Transcutaneous electrical stimulation electrode, single-use