K210768 is an FDA 510(k) clearance for the Wrist Blood Pressure Monitor, Blood Pressure Monitor. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 30, 2021, 137 days after receiving the submission on March 15, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K210768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2021 |
| Decision Date | July 30, 2021 |
| Days to Decision | 137 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |