FDA 510(k) Application Details - K042948

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K042948
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant WANDONG MEDICAL
NO. 7 SANJIANFANG NANLI
CHAOYANG DISTRICT
BEIJING 100024 CN
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Contact WANG WEIMIN
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 10/26/2004
Decision Date 11/03/2004
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

FDA Source Information for K042948


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