FDA 510(k) Application Details - K221329

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K221329
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Phelcom Technologies Rua JosΘ Missali, 820 - Santa Felφcia Sπo Carlos 13562-405 BR Other 510(k) Applications for this Company
Contact	Flßvio Pascoal Vieira Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2022
Decision Date	02/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review