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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 K243339
Device Name WiTOF
Applicant
Idmed
3 Rue John Maynard Keynes
Marseille,  FR 13013
Applicant Contact Aurelie Gruener
Correspondent
Idmed
3 Rue John Maynard Keynes
Marseille,  FR 13013
Correspondent Contact Perrine Moelle
Regulation Number868.2775
Classification Product Code
KOI  
Date Received10/25/2024
Decision Date 06/23/2025
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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