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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K102507
Device Name AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
Applicant
Tz Medical, Inc.
7272 SW Durham Rd., #800
Portland,  OR  97224
Applicant Contact JOHN LUBISICH
Correspondent
Tz Medical, Inc.
7272 SW Durham Rd., #800
Portland,  OR  97224
Correspondent Contact JOHN LUBISICH
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/01/2010
Decision Date 06/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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