K112216 is an FDA 510(k) clearance for the U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 22, 2011, 142 days after receiving the submission on August 2, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K112216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2011 |
| Decision Date | December 22, 2011 |
| Days to Decision | 142 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 |