FDA 510(k) Application Details - K230730

Device Classification Name	More FDA Info for this Device
510(K) Number	K230730
Device Name	Apyx
Applicant	Escala Medical 17 Tchelet Street Misgav 2017400 IL Other 510(k) Applications for this Company
Contact	Edit Goldberg Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2023
Decision Date	07/25/2023
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