K162089 is an FDA 510(k) clearance for the Blood Pressure Monitor. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Beijing Choice Electronic Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 10, 2017, 197 days after receiving the submission on July 28, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K162089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2016 |
| Decision Date | February 10, 2017 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| 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 |