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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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