FDA 510(k) Application Details - K012005

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K012005
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 TERESA DAVIDSON
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 06/27/2001
Decision Date 07/24/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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