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FDA 510(k) Application Details - K081891
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K081891
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
FUKUDA DENSHI USA, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
870.1025
More FDA Info for this Regulation Number
Classification Product Code
MHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/02/2008
Decision Date
08/29/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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