FDA 510(k) Application Details - K180123

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K180123
Device Name Coil, Magnetic Resonance, Specialty
Applicant Noras MRI products GmbH
Leibnizstrasse 4
Hoechberg 97204 DE
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Contact Jens Heidenmann
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 01/16/2018
Decision Date 02/16/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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