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510(k) K153707

Nihon Kohden Vital Sign Telemeter by Nihon Kohden Corporation — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2016
Date Received
December 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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