K014262 is an FDA 510(k) clearance for the COSMED QUARK C12/QUARK T12. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on March 26, 2002, 89 days after receiving the submission on December 27, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K014262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2001 |
| Decision Date | March 26, 2002 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |