K223622 is an FDA 510(k) clearance for the FaceHeart Vitals Software Development Kit (FH vitals SDK). This device is classified as a Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (Class II - Special Controls, product code QME).
Submitted by Faceheart Corp. (Grand Cayman, KY). The FDA issued a Cleared decision on September 1, 2023, 270 days after receiving the submission on December 5, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2785. 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..
| 510(k) Number | K223622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2022 |
| Decision Date | September 01, 2023 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QME - Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2785 |
| Definition | 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. |