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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 K973527
Device Name CARDIO-PAGER SYSTEM
Applicant
Data Critical Corp.
2733 152nd Ave. NE
Redmond,  WA  98052
Applicant Contact TED SCHMUHL
Correspondent
Data Critical Corp.
2733 152nd Ave. NE
Redmond,  WA  98052
Correspondent Contact TED SCHMUHL
Regulation Number870.2300
Classification Product Code
MSX  
Date Received09/18/1997
Decision Date 03/31/1998
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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