FDA 510(k) Application Details - K050919

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K050919
Device Name Detector And Alarm, Arrhythmia
Applicant ANALOGIC CORP.
8 CENTENNIAL DR.
CENTENNIAL INDUSTRIAL PARK
PEABODY, MA 01960 US
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Contact DONALD SHERRATT
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 04/12/2005
Decision Date 06/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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