PHILIPS TOMOSCAN SR 4000

System, X-ray, Tomography, Computed

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 Tomoscan Sr 4000.

Pre-market Notification Details

Device IDK936272
510k NumberK936272
Device Name:PHILIPS TOMOSCAN SR 4000
ClassificationSystem, X-ray, Tomography, Computed
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 CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-30
Decision Date1994-10-11

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