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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K992848
Device Name ALARMVIEW SYSTEM
Applicant
DATA CRITICAL CORP.
19820 NORTH CREEK PKWY.
#100
BOTHELL,  WA  98011
Applicant Contact DREW WEAVER
Correspondent
DATA CRITICAL CORP.
19820 NORTH CREEK PKWY.
#100
BOTHELL,  WA  98011
Correspondent Contact DREW WEAVER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received08/24/1999
Decision Date 11/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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