The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Intellivue Clinical Information Portfolio.
Device ID | K100272 |
510k Number | K100272 |
Device Name: | INTELLIVUE CLINICAL INFORMATION PORTFOLIO |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Teresa Schmidt |
Correspondent | Teresa Schmidt PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-29 |
Decision Date | 2010-04-14 |
Summary: | summary |