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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K213717
Device Name AIR Recon DL
Applicant
GE Medical Systems,LLC (GE Healthcare)
3200 N Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Glen Sabin
Correspondent
GE Medical Systems,LLC (GE Healthcare)
3200 N Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Glen Sabin
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/24/2021
Decision Date 06/08/2022
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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