FDA 510(k) Application Details - K241733

Device Classification Name	More FDA Info for this Device
510(K) Number	K241733
Device Name	HEBE (NP0000763)
Applicant	Novasonix Technology S.L c/ Pla de Ramasar 52, Pol. Ind, Carrer Pla del Ramassar Granollers 08402 ES Other 510(k) Applications for this Company
Contact	Carlos Navarro Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2024
Decision Date	04/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review