PHILIPS BV-29 IMAGING SYSTEM

Image-intensified Fluoroscopic X-ray System, Mobile

PHILIPS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Bv-29 Imaging System.

Pre-market Notification Details

Device IDK910115
510k NumberK910115
Device Name:PHILIPS BV-29 IMAGING SYSTEM
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best,  NL
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best,  NL
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-10
Decision Date1991-02-20

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