510(k) DEN200019
DEN200019 is an FDA 510(k) premarket notification submitted by Oxehealth Limited for the device "Oxehealth Vital Signs". The FDA issued a decision of De Novo Granted on March 26, 2021. The device falls under product code QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate), a Class II device regulated under 21 CFR 870.2785. Oxehealth Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 26, 2021
- Date Received
- March 27, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
- Device Class
- Class II
- Regulation Number
- 870.2785
- Review Panel
- CV
- Submission Type
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.