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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 K261098
Device Name TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
Applicant
Senzime AB
Verkstadsgatan 8
Uppsala,  SE 75323
Applicant Contact Johanna Faris
Correspondent
Obelix Consulting, LLC
806 Jefferson St.
Bastrop,  TX  78602
Correspondent Contact Elisa Maldonado-Holmertz
Regulation Number868.2775
Classification Product Code
KOI  
Date Received04/02/2026
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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