NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH

Coil, Magnetic Resonance, Specialty

NORAS MRI PRODUCTS GMBH

The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Or Head Holder S17000-mq/ Noras Or Head Coil 3t 7230-ph Model S1700-mq/ 7230-ph.

Pre-market Notification Details

Device IDK093693
510k NumberK093693
Device Name:NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
ClassificationCoil, Magnetic Resonance, Specialty
Applicant NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg,  DE 97204
ContactZahed Sedighiani
CorrespondentZahed Sedighiani
NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg,  DE 97204
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-30
Decision Date2010-01-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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04251269206856 K093693 000

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