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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 K012005
Device Name MODIFICATION TO 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 Received06/27/2001
Decision Date 07/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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