510(k) K243687
K243687 is an FDA 510(k) premarket notification submitted by Oxehealth Limited for the device "Vital Signs". The FDA issued a decision of Substantially Equivalent on August 27, 2025. 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
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2025
- Date Received
- November 29, 2024
- Clearance Type
- Traditional
- 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.