FDA 510(k) Application Details - K213783

Device Classification Name	More FDA Info for this Device
510(K) Number	K213783
Device Name	Apyx
Applicant	Escala Medical 17th Tchelet Street Misgav Industrial Park 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	12/03/2021
Decision Date	04/05/2022
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