SYNERGY HEAD/NECK COIL

Coil, Magnetic Resonance, Specialty

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 Synergy Head/neck Coil.

Pre-market Notification Details

Device IDK001331
510k NumberK001331
Device Name:SYNERGY HEAD/NECK COIL
ClassificationCoil, Magnetic Resonance, Specialty
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 CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-27
Decision Date2000-06-09

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