K091513 is an FDA 510(k) clearance for the SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on July 24, 2009, 63 days after receiving the submission on May 22, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K091513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2009 |
| Decision Date | July 24, 2009 |
| Days to Decision | 63 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 |