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510(k) K250887

Neuromuscular Transmission Monitor TOF3D (2510091) by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2025
Date Received
March 25, 2025
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

  • K212434 — Neuromuscular Transmission Monitor TOF3D (May 5, 2022)

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  • K192958 — TwitchView System (April 2, 2020)
  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)
  • K172690 — ToFscan (May 31, 2018)