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The Dream Sock analyzes photoplethysmography data to identify instances when the infant’s
pulse rate (PR) and/or oxygen saturation (SpO2) moves outside a preset range, and
provides a notification to the caregiver, prompting them to assess the infant. The Dream
Sock also displays the infant’s PR and SpO2 values to the caregiver and displays trends in
these measured values, and their relationship to the preset ranges, over time. These PR and
SpO2 notifications and displays on the Dream Sock are intended for use in infants who are 1
to 18 months of age and between 6 to 30 lbs.
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00810099091212 ()
- Multiple vital physiological parameter monitoring system, home-use
Dream Sock Software App.
The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not
intended to provide notification for every episode of the unexpected occurrences of elevated or
depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only
when sufficient data are available for analysis. The notifications and associated data can be used to
supplement the decision by caregivers to seek additional guidance for medical care of the infant. The
Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution
- 00810099090819 ()
- Multiple vital physiological parameter monitoring system, home-use
BabySat unit composed of one base station, one sensor, two socks and the App.
The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen
saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or
continuous monitoring of well-perfused patients greater than one month old up to 18 months old and
weighing between 6 and 30 lbs., in the home environment
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution
- 00810099090086 ()
- 00810099090192 ()
- 10810099090199 ()
- Multiple vital physiological parameter monitoring system, home-use
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution
- 00810099090079 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
Owlet Baby Care, Inc.
OSS 3.0-M1
In Commercial Distribution
- 00810099090031 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
Owlet Baby Care, Inc.
OBL 3.0-M1
In Commercial Distribution
- 00810099090024 ()
- Multiple vital physiological parameter monitoring system, home-use
THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.
Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound.
THD SPA
THD HRStation
In Commercial Distribution
- 58051887042642 ()
800299
- Ultrasound imaging system application software
A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
Not in Commercial Distribution
- 72900130302906 ()
CMMST5S
- Multiple vital physiological parameter monitoring system, clinical
THD DIGITAL MOBILE LIGHT is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform digital anoscopy, anorectal manometry and Transanal Ultrasound using dedicated hardwares.
THD DIGITAL MOBILE LIGHT has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004).
THD SPA
THD DIGITAL MOBILE LIGHT
In Commercial Distribution
- 68051887046715 ()
800320
- Ultrasound imaging system application software
THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry and Transanal Ultrasound.
THD DIGITAL MOBILE ADVANCED has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes, THD Anopress (transportable anorectal manometer) for anorectal manometry and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ADVANCED
In Commercial Distribution
- 68051887043325 ()
800309
- Ultrasound imaging system application software