K190775 is an FDA 510(k) clearance for the The RHEA Vital Sign Vigilance System. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Shenzhen Fiber Medical Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 19, 2019, 268 days after receiving the submission on March 26, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K190775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2019 |
| Decision Date | December 19, 2019 |
| Days to Decision | 268 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 |