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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 K172690
Device Name ToFscan
Applicant
Idmed
Hotel Technoptic - 2 rue Marc Donadille
Marseille,  FR 13013
Applicant Contact Frédéric BERNERT
Correspondent
Idmed
Hotel Technoptic - 2 rue Marc Donadille
Marseille,  FR 13013
Correspondent Contact Frédéric BERNERT
Regulation Number868.2775
Classification Product Code
KOI  
Date Received09/06/2017
Decision Date 05/31/2018
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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