K080319 is an FDA 510(k) clearance for the KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Andon Health Co, Ltd. (Tiajin, CN). The FDA issued a Cleared decision on July 2, 2008, 147 days after receiving the submission on February 6, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K080319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2008 |
| Decision Date | July 02, 2008 |
| Days to Decision | 147 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 |