FDA 510(k) Application Details - K033315

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K033315
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
NO.3-11, WENHUA ROAD
HEPING DISTRICT
SHENYANG, LIAONING 110004 CN
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Contact WANG ZHIQIANG
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 10/15/2003
Decision Date 10/29/2003
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 Y
Expedited Review



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