Cardiovascular · De Novo · 2021
Oxehealth Vital Signs
Oxehealth Limited. Granted by FDA on 26 March 2021 under submission DEN200019, product code QME (software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate). What FDA's record says, in FDA's words.
Device record · DEN200019
- Device. Oxehealth Vital SignsDEVICE
- Company. Oxehealth LimitedCOMPANY
- Decision. 26 March 2021, De NovoDECISION
- Panel. CardiovascularPANEL
- Product code. QME, Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory RateCODE
- Regulation. 21 CFR 870.2785, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. 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.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QME. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QME, in Cardiovascular, from Oxehealth Limited, or granted in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.