Devices · Oxehealth Limited

Oxehealth Vital Signs

Oxehealth Limited is listed for Oxehealth Vital Signs (DEN200019). The FDA list gives March 26, 2021 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QME as “Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate”: The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200019

Official FDA database record

Date of final decision

March 26, 2021

Company on the FDA list

Oxehealth Limited

Lead panel

Cardiovascular

Primary product code

QME

openFDA device name for the code

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Device class

2

Regulation number

870.2785

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned