FDA 510(k) Application Details - K202238

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K202238
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road,Tianjin Airport Economic Area
Tianjin 300308 CN
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Contact Qiang Ding
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 08/07/2020
Decision Date 09/04/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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