PHILIPS INTEGRIS V5000 AND BV5000

System, X-ray, Angiographic

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 Integris V5000 And Bv5000.

Pre-market Notification Details

Device IDK973482
510k NumberK973482
Device Name:PHILIPS INTEGRIS V5000 AND BV5000
ClassificationSystem, X-ray, Angiographic
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 CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-15
Decision Date1997-11-10
Summary:summary

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