The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Easi 12 Lead Algorithm.
| Device ID | K020456 |
| 510k Number | K020456 |
| Device Name: | EASI 12 LEAD ALGORITHM |
| Classification | Adaptor, Lead Switching, Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS 1201B NORTH RICE AVE. Oxnard, CA |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader PHILIPS MEDICAL SYSTEMS 1201B NORTH RICE AVE. Oxnard, CA |
| Product Code | DRW |
| CFR Regulation Number | 870.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-11 |
| Decision Date | 2002-07-09 |
| Summary: | summary |