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FDA 510(k) Application Details - K050919
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
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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