K132627 is an FDA 510(k) clearance for the AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Honsun (Nantong) Co., Ltd. (Nantong, Jiangsu, CN). The FDA issued a Cleared decision on October 23, 2013, 62 days after receiving the submission on August 22, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K132627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2013 |
| Decision Date | October 23, 2013 |
| Days to Decision | 62 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 |