The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Modification Of Philips Component Compact Monitor, Release A.03, Model M1275b.
| Device ID | K021300 |
| 510k Number | K021300 |
| Device Name: | MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-24 |
| Decision Date | 2002-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838010291 | K021300 | 000 |
| 00884838010284 | K021300 | 000 |
| 00884838010260 | K021300 | 000 |
| 00884838010246 | K021300 | 000 |
| 00884838102699 | K021300 | 000 |
| 00884838102705 | K021300 | 000 |
| 00884838102712 | K021300 | 000 |