K183535 is an FDA 510(k) clearance for the Fully Automatic Electronic 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 June 4, 2019, 167 days after receiving the submission on December 19, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K183535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2018 |
| Decision Date | June 04, 2019 |
| Days to Decision | 167 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 |