K211387 is an FDA 510(k) clearance for the Breathe Easy Mobile Respiratory Monitor (MRM). This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Sound Life Sciences, Inc. (Seattle, US). The FDA issued a Cleared decision on November 23, 2021, 202 days after receiving the submission on May 5, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K211387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZQ - Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |