K101569 is an FDA 510(k) clearance for the V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on March 1, 2011, 270 days after receiving the submission on June 4, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K101569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2010 |
| Decision Date | March 01, 2011 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |