PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION

System, X-ray, Fluoroscopic, Image-intensified

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Cd Medical Recorder, View Station, Dup[[lication Station.

Pre-market Notification Details

Device IDK945460
510k NumberK945460
Device Name:PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactPeter Altman
CorrespondentPeter Altman
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-07
Decision Date1995-03-14

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