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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 K010912
Device Name ALARMVIEW WIRELESS DATA NETWORK SYSTEM
Applicant
Data Critical Corp.
19820 N. Creek Pkwy.
#100
Bothell,  WA  98011
Applicant Contact TERESA DAVIDSON
Correspondent
Data Critical Corp.
19820 N. Creek Pkwy.
#100
Bothell,  WA  98011
Correspondent Contact TERESA DAVIDSON
Regulation Number870.2300
Classification Product Code
MSX  
Date Received03/27/2001
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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