K091397 is an FDA 510(k) clearance for the ECSCOPE 200. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Dyansys, Inc. (Burlingame, US). The FDA issued a Cleared decision on July 8, 2009, 57 days after receiving the submission on May 12, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K091397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2009 |
| Decision Date | July 08, 2009 |
| Days to Decision | 57 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 |