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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
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