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510(k) K203435

Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System by Nihon Kohden Corporation — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2021
Date Received
November 23, 2020
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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