K100658 is an FDA 510(k) clearance for the U-RIGHT TD-3127 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 (Taipei County, TW). The FDA issued a Cleared decision on July 9, 2010, 123 days after receiving the submission on March 8, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K100658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2010 |
| Decision Date | July 09, 2010 |
| Days to Decision | 123 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 |