Cleared Traditional

Neuromuscular Transmission Monitor TOF3D

K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · Anesthesiology

May 2022

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K212434 is an FDA 510(k) clearance for the Neuromuscular Transmission Monitor TOF3D, a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by MIPM Mammendorfer Institut f?r Physik und Medizin GmbH (Mammendorf, DE). The FDA issued a Cleared decision on May 5, 2022, 274 days after receiving the submission on August 4, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number	K212434 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2021
Decision Date	May 05, 2022
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF