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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 K220530
Device Name Tetragraph Neuromuscular Transmission Monitor
Applicant
Senzime AB
Ulls Vag 41
Uppsala,  SE 75651
Applicant Contact Johanna Faris
Correspondent
Obelix Consulting
12416 Fairfax Ridge Place
Austin,  TX  78738
Correspondent Contact Elisa Maldonado-Holmertz
Regulation Number868.2775
Classification Product Code
KOI  
Date Received02/24/2022
Decision Date 08/17/2022
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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