HAC-300 HEAD ARRAY COIL

Coil, Magnetic Resonance, Specialty

MRI DEVICES CORP.

The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Hac-300 Head Array Coil.

Pre-market Notification Details

Device IDK001944
510k NumberK001944
Device Name:HAC-300 HEAD ARRAY COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha,  WI  53186
ContactTom Schubert
CorrespondentTom Schubert
MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha,  WI  53186
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-26
Decision Date2000-08-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838080898 K001944 000

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