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FDA 510(k) Application Details - K150030
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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510(K) Number
K150030
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
Fukuda Denshi USA, Inc.
17725 NE 65th St, Building C
Redmond, WA 98052 US
Other 510(k) Applications for this Company
Contact
Doug Blakely
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
Date Received
01/08/2015
Decision Date
03/16/2015
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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