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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 K111160
Device Name INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
Applicant
INTRICON DATRIX CORPORATION
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact TANYA O'BRIEN
Correspondent
INTRICON DATRIX CORPORATION
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact TANYA O'BRIEN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/25/2011
Decision Date 08/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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