FDA 510(k) Application Details - K243291

Device Classification Name	Electrode, Circular (Spiral), Scalp And Applicator   More FDA Info for this Device
510(K) Number	K243291
Device Name	Electrode, Circular (Spiral), Scalp And Applicator
Applicant	Neoventa Medical AB Norra ┼gatan 32 M÷lndal SE-431 35 SE Other 510(k) Applications for this Company
Contact	Johan Sundberg Other 510(k) Applications for this Contact
Regulation Number	884.2675   More FDA Info for this Regulation Number
Classification Product Code	HGP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	01/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review