K131395 is an FDA 510(k) clearance for the TRANSTEK BLOOD PRESSURE MONITOR. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Guangdong Transtek Medical Electronics Co., Ltd. (Chengdu, Sichuan, CN). The FDA issued a Cleared decision on June 19, 2013, 35 days after receiving the submission on May 15, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K131395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2013 |
| Decision Date | June 19, 2013 |
| Days to Decision | 35 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 |