K233953 is an FDA 510(k) clearance for the Makani Science™ Respiration Monitoring System. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Makani Science, Inc. (Irvine, US). The FDA issued a Cleared decision on March 28, 2025, 469 days after receiving the submission on December 15, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K233953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | March 28, 2025 |
| Days to Decision | 469 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 |