The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Easi Ecg Algorithm.
| Device ID | K033513 |
| 510k Number | K033513 |
| Device Name: | EASI ECG ALGORITHM |
| Classification | Adaptor, Lead Switching, Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | David Osborn |
| Correspondent | David Osborn PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DRW |
| CFR Regulation Number | 870.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-06 |
| Decision Date | 2004-01-15 |
| Summary: | summary |