SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5

Table, Radiologic

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 Syncra Tilt Option For Angio Diagnost 5.

Pre-market Notification Details

Device IDK940696
510k NumberK940696
Device Name:SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
ClassificationTable, Radiologic
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 CodeKXJ  
CFR Regulation Number892.1980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-16
Decision Date1994-03-16

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