K212622 is an FDA 510(k) clearance for the Zyter RPM. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Zyter, Inc. (Rockville, US). The FDA issued a Cleared decision on February 11, 2022, 177 days after receiving the submission on August 18, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K212622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2021 |
| Decision Date | February 11, 2022 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX - System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |