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 |