K043437 is an FDA 510(k) clearance for the FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET. 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. (Chung Ho City, Taipei, Hsien, TW). The FDA issued a Cleared decision on January 12, 2005, 30 days after receiving the submission on December 13, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K043437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2004 |
| Decision Date | January 12, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |