INTELLIVUE CLINICAL INFORMATION PORTFOLIO

Display, Cathode-ray Tube, Medical

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Intellivue Clinical Information Portfolio.

Pre-market Notification Details

Device IDK100272
510k NumberK100272
Device Name:INTELLIVUE CLINICAL INFORMATION PORTFOLIO
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactTeresa Schmidt
CorrespondentTeresa Schmidt
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-29
Decision Date2010-04-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.