FDA 510(k), K102507, AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

FDA 510(k), K102507, AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

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510(K) Number: K102507
Device Name: AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
Manufacturer: TZ MEDICAL, INC.
Device Classification Name: detector and alarm, arrhythmia
Regulation Number: 870.1025
Classification Product Code: DSI
Date Received: 09/01/2010
Decision Date: 06/13/2011
Regulation Medical Specialty: Cardiovascular

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