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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 K190795
Device Name Tetragraph Neuromuscular Transmission Monitor
Applicant
Senzime AB
Ulls Vag 29b
Uppsala,  SE 756 51
Applicant Contact Johanna Faris
Correspondent
Obleix Consulting, LLC
12416 Fairfax Ridge Place
Austin,  TX  78738
Correspondent Contact Elisa Maldonado-Holmertz
Regulation Number868.2775
Classification Product Code
KOI  
Date Received03/28/2019
Decision Date 10/18/2019
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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