K243966 is an FDA 510(k) clearance for the FaceHeart Vitals Software Development Kit (FH vitals SDK-RR). This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Faceheart Corp. (Grand Cayman, KY). The FDA issued a Cleared decision on April 9, 2025, 107 days after receiving the submission on December 23, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K243966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2024 |
| Decision Date | April 09, 2025 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZQ - Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |