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FDA 510(k) Application Details - K020084
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K020084
Device Name
Detector And Alarm, Arrhythmia
Applicant
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND, WA 98052-4911 US
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Contact
LARRY D WALKER
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
01/10/2002
Decision Date
02/06/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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