FDA 510(k) Application Details - K962811

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K962811
Device Name Display, Cathode-Ray Tube, Medical
Applicant SPACELABS MEDICAL, INC.
P.O. BOX 97013
REDMOND, WA 98073-9713 US
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Contact RUSS GARRISON
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 07/18/1996
Decision Date 06/24/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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