510(k) K223622
K223622 is an FDA 510(k) premarket notification submitted by Faceheart Corp. for the device "FaceHeart Vitals Software Development Kit (FH vitals SDK)". The FDA issued a decision of Substantially Equivalent on September 1, 2023. 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. Faceheart Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2023
- Date Received
- December 5, 2022
- 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.