K012310 is an FDA 510(k) clearance for the MODIFICATION TO:HL168D 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. (Taipei Hsien, TW). The FDA issued a Cleared decision on August 22, 2001, 30 days after receiving the submission on July 23, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K012310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2001 |
| Decision Date | August 22, 2001 |
| 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 |