K091997 is an FDA 510(k) clearance for the FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962. 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. (Tianjin, CN). The FDA issued a Cleared decision on July 30, 2009, 28 days after receiving the submission on July 2, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K091997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2009 |
| Decision Date | July 30, 2009 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |