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510(k) K212434

Neuromuscular Transmission Monitor TOF3D by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2022
Date Received
August 4, 2021
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 MIPM Mammendorfer Institut für Physik und Medizin GmbH

  • K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) (October 21, 2025)

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  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)
  • K172690 — ToFscan (May 31, 2018)