FDA 510(k) Application Details - K160935

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K160935
Device Name Coil, Magnetic Resonance, Specialty
Applicant Shenzhen RF Tech Co., Ltd.
2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming
Shenzhen 518132 CN
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Contact Ke Xi
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 04/04/2016
Decision Date 07/28/2016
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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