K930786 is an FDA 510(k) clearance for the EPCOR. This device is classified as a Adaptor, Lead Switching, Electrocardiograph (Class II - Special Controls, product code DRW).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on September 26, 1994, 587 days after receiving the submission on February 16, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2350.
| 510(k) Number | K930786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1993 |
| Decision Date | September 26, 1994 |
| Days to Decision | 587 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRW — Adaptor, Lead Switching, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2350 |