The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Component Compact Monitor, Release A.04, Model #m1275b.
| Device ID | K021778 |
| 510k Number | K021778 |
| Device Name: | PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B |
| Classification | Oximeter |
| 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 | DQA |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-30 |
| Decision Date | 2002-07-17 |
| Summary: | summary |