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510(k) K152305

Nihon Kohden Afib Detection Program QP-039P by Nihon Kohden Corporation — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2016
Date Received
August 14, 2015
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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