FDA 510(k) Application Details - K960809

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K960809
Device Name System, Digital Image Communications, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON, CT 06484 US
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Contact TIMOTHY W CAPEHART
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 02/28/1996
Decision Date 04/07/1996
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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