PHILIPS TOMOSCAN SR 8000

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 8000.

Pre-market Notification Details

Device IDK954255
510k NumberK954255
Device Name:PHILIPS TOMOSCAN SR 8000
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactTimothy W Capehart
CorrespondentTimothy W Capehart
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 Received1995-09-11
Decision Date1995-10-07

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