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510(k) K201949

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series by Nihon Kohden Corporation — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2021
Date Received
July 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

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