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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 K130339
Device Name CLINICAL ALERT NOTIFICATION
Applicant
Extension , Inc.
7250 SW 154th Ter.
Beaverton,  OR  97007
Applicant Contact TIM GEE
Correspondent
Extension , Inc.
7250 SW 154th Ter.
Beaverton,  OR  97007
Correspondent Contact TIM GEE
Regulation Number870.2300
Classification Product Code
MSX  
Date Received02/11/2013
Decision Date 07/11/2013
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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