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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K163661
Device Name P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
Applicant
RAPID Biomedical GmbH
Kettelerstr. 3-11
Rimpar,  DE 97222
Applicant Contact Christian Zimmermann
Correspondent
RAPID Biomedical GmbH
Kettelerstr. 3-11
Rimpar,  DE 97222
Correspondent Contact Christian Zimmermann
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/27/2016
Decision Date 03/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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