FDA 510(k) Application Details - K061534

Device Classification Name

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510(K) Number K061534
Device Name ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
Applicant ZIEHM IMAGING, INC.
4181 LATHAM ST.
RIVERSIDE, CA 92501 US
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Contact RICHARD WESTRICH
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Regulation Number

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Classification Product Code OWB
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Date Received 06/02/2006
Decision Date 07/07/2006
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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