FDA 510(k) Application Details - K243339

Device Classification Name	Stimulator, Nerve, Peripheral, Electric   More FDA Info for this Device
510(K) Number	K243339
Device Name	Stimulator, Nerve, Peripheral, Electric
Applicant	IDMED 3 rue John Maynard Keynes Marseille 13013 FR Other 510(k) Applications for this Company
Contact	Aurelie Gruener Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	KOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2024
Decision Date	06/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review