K113239 is an FDA 510(k) clearance for the FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF). 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 March 16, 2012, 135 days after receiving the submission on November 2, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K113239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2011 |
| Decision Date | March 16, 2012 |
| Days to Decision | 135 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 |