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510(k) K220530

Tetragraph Neuromuscular Transmission Monitor by Senzime AB — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2022
Date Received
February 24, 2022
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

  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)

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