FDA 510(k) Application Details - K961876

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K961876
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC.
1963 CASE PKWY.
TWINSBURG, OH 44087 US
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Contact JAMES J ROGERS
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 05/15/1996
Decision Date 07/25/1996
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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