The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Multi-parameter Module, Model M3001a; Philips Component Compact Monitor, Release A.02, Model M1275b.
| Device ID | K020531 |
| 510k Number | K020531 |
| Device Name: | PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Dave Osborn |
| Correspondent | Dave Osborn PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-03-20 |
| Summary: | summary |