PHILIPS GYROVIEW HR - RELEASE 2

System, Nuclear Magnetic Resonance Imaging

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 Gyroview Hr - Release 2.

Pre-market Notification Details

Device IDK923944
510k NumberK923944
Device Name:PHILIPS GYROVIEW HR - RELEASE 2
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-05
Decision Date1993-04-27

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