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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 K213480
Device Name 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
Applicant
Rapid Biomedical GmbH
Kettelerstr. 3-11
Rimpar,  DE 97222
Applicant Contact Marius Berthel
Correspondent
Rapid Biomedical GmbH
Kettelerstr. 3-11
Rimpar,  DE 97222
Correspondent Contact Marius Berthel
Regulation Number892.1000
Classification Product Code
MOS  
Date Received10/29/2021
Decision Date 02/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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