PHILIPS BV 300 SERIES

Image-intensified Fluoroscopic X-ray System, Mobile

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 Bv 300 Series.

Pre-market Notification Details

Device IDK953910
510k NumberK953910
Device Name:PHILIPS BV 300 SERIES
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
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 CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-21
Decision Date1995-10-18
Summary:summary

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