FDA 510(k) Application Details - K010850

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K010850
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant ODIN MEDICAL TECHNOLOGIES LTD.
P.O. BOX 248
YOKNEAM ELIT 20692 IL
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Contact ADI ICKOWICZ
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 03/21/2001
Decision Date 12/17/2001
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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