FDA 510(k) Application Details - K955184

Device Classification Name Device, Digital Image Storage, Radiological

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510(K) Number K955184
Device Name Device, Digital Image Storage, Radiological
Applicant E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
625 ALASKA AVE.
TORRANCE, CA 90503-5124 US
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Contact STU BUSH
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Regulation Number 892.2010

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Classification Product Code LMB
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Date Received 11/13/1995
Decision Date 01/24/1996
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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