K190507 is an FDA 510(k) clearance for the Full Automatic (NIBP) Blood Pressure Monitor. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Health & Life Co., Ltd. (Zhonghe District, New Taipei City, TW). The FDA issued a Cleared decision on September 16, 2019, 199 days after receiving the submission on March 1, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K190507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2019 |
| Decision Date | September 16, 2019 |
| Days to Decision | 199 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 |