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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K250887
Device Name Neuromuscular Transmission Monitor TOF3D (2510091)
Applicant
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Oskar-Von-Miller St. 6-7
Mammendorf,  DE 82291
Applicant Contact Sebastian Wörl
Correspondent
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Oskar-Von-Miller St. 6-7
Mammendorf,  DE 82291
Correspondent Contact Sebastian Wörl
Regulation Number868.2775
Classification Product Code
KOI  
Date Received03/25/2025
Decision Date 10/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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