K200445 is an FDA 510(k) clearance for the The C100 Contactless Breathing Monitor. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Circadia Technologies, Ltd. (Croydon, GB). The FDA issued a Cleared decision on June 24, 2020, 121 days after receiving the submission on February 24, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K200445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2020 |
| Decision Date | June 24, 2020 |
| Days to Decision | 121 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 |