K033513 is an FDA 510(k) clearance for the EASI ECG ALGORITHM. This device is classified as a Adaptor, Lead Switching, Electrocardiograph (Class II - Special Controls, product code DRW).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on January 15, 2004, 70 days after receiving the submission on November 6, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2350.
| 510(k) Number | K033513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2003 |
| Decision Date | January 15, 2004 |
| Days to Decision | 70 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 |