FDA 510(k) Application Details - K974882

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K974882
Device Name System, Digital Image Communications, Radiological
Applicant MERLIN ENGINEERING WORKS, INC.
1888 EMBARCADERO RD.
PALO ALTO, CA 94303 US
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Contact GERALD ENGBRETSON
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 12/30/1997
Decision Date 05/22/1998
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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