FDA 510(k) Application Details - K990378

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K990378
Device Name System,Network And Communication,Physiological Monitors
Applicant DATA CRITICAL CORP.
19820 NORTH CREEK PKWY.
#100
BOTHELL, WA 98011 US
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Contact DREW WEAVER
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 02/08/1999
Decision Date 09/20/1999
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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