FDA 510(k) Application Details - K043271

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K043271
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant INNER VISION BIOMETRICS PTY LTD
216 STIRLING HWY
CLAREMONT, PERTH 6010 AU
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Contact JANET PREUSS
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 11/26/2004
Decision Date 01/21/2005
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

FDA Source Information for K043271


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