K250934 is an FDA 510(k) clearance for the Respiree Cardio- Respiratory Monitor System. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Respiree Pte, Ltd. (Singapore Central, SG). The FDA issued a Cleared decision on August 5, 2025, 130 days after receiving the submission on March 28, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K250934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2025 |
| Decision Date | August 05, 2025 |
| Days to Decision | 130 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 |