K210160 is an FDA 510(k) clearance for the AlertWatch:AC. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Alertwatch, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on September 10, 2021, 232 days after receiving the submission on January 21, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K210160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2021 |
| Decision Date | September 10, 2021 |
| Days to Decision | 232 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 |