K090058 is an FDA 510(k) clearance for the YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Ya Horng Electronic Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on April 22, 2009, 104 days after receiving the submission on January 8, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K090058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2009 |
| Decision Date | April 22, 2009 |
| Days to Decision | 104 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 |