K221555 is an FDA 510(k) clearance for the Dozee VS. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Turtle Shell Technologies Private Limited (Bengaluru, IN). The FDA issued a Cleared decision on December 15, 2022, 198 days after receiving the submission on May 31, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K221555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2022 |
| Decision Date | December 15, 2022 |
| Days to Decision | 198 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 |