The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Telemedicine Server/system, Model 861441.
Device ID | K091176 |
510k Number | K091176 |
Device Name: | PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. M/S 0220 Andover, MA 01810 |
Contact | Paul Schrader |
Correspondent | Paul Schrader PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. M/S 0220 Andover, MA 01810 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-22 |
Decision Date | 2009-11-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838041530 | K091176 | 000 |
00884838040878 | K091176 | 000 |
00884838040861 | K091176 | 000 |