FDA 510(k) Application Details - K232273

Device Classification Name	Electrode, Corneal   More FDA Info for this Device
510(K) Number	K232273
Device Name	Electrode, Corneal
Applicant	RetMap, Inc. 832 W Superior St, Suite 202 Chicago, IL 60642 US Other 510(k) Applications for this Company
Contact	Shresta Patangay Other 510(k) Applications for this Contact
Regulation Number	886.1220   More FDA Info for this Regulation Number
Classification Product Code	HLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2023
Decision Date	12/07/2023
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