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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 K102757
Device Name LIFENET SYSTEM
Applicant
Physio-Control, Inc.
11811 Willows Rd. Northeast
P.O. Box 97006
Redmond,  WA  98073
Applicant Contact TERESA DAVIDSON
Correspondent
Physio-Control, Inc.
11811 Willows Rd. Northeast
P.O. Box 97006
Redmond,  WA  98073
Correspondent Contact TERESA DAVIDSON
Regulation Number870.2300
Classification Product Code
MSX  
Date Received09/23/2010
Decision Date 11/05/2010
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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