FDA 510(k) Application Details - K992749

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K992749
Device Name System,Network And Communication,Physiological Monitors
Applicant SPACELABS MEDICAL, INC.
15220 NORTH EAST 40TH ST.
P.O. BOX 97013
REDMOND, WA 98052 US
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Contact NANCY GERTLAR
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 08/16/1999
Decision Date 01/14/2000
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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