7 devices · 3 companies · 2021 to 2026
Product code QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
7 devices under product code QME, 2021 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 7 here), the regulation, and MAUDE report counts by product code.
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate. 21 CFR 870.2785, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Vital SignsK251200 · 510(k) | Oxehealth Limited | Cardiovascular | database entry | |
| Vital SignsK243687 · 510(k) | Oxehealth Limited | Cardiovascular | database entry | |
| Informed Vital Core ApplicationK241633 · 510(k) | Mindset Medical, Inc. | Cardiovascular | database entry | |
| FaceHeart Vitals Software Development KitK223622 · 510(k) | FaceHeart Corp. | Cardiovascular | database entry | |
| Oxehealth Vital SignsK220899 · 510(k) | Oxehealth Limited | Cardiovascular | database entry | |
| Vital SignsK211906 · 510(k) | Oxehealth Limited | Cardiovascular | database entry | |
| Oxehealth Vital SignsDEN200019 · De Novo | Oxehealth Limited | Cardiovascular | database entry |
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