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510(k) K190795

Tetragraph Neuromuscular Transmission Monitor by Senzime AB — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2019
Date Received
March 28, 2019
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

Other clearances by Senzime AB

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