FDA 510(k) Application Details - K221183

Device Classification Name	More FDA Info for this Device
510(K) Number	K221183
Device Name	AEYE-DS
Applicant	AEYE Health, Inc. 200 Park Avenue (17th Floor) New York, NY 10166 US Other 510(k) Applications for this Company
Contact	Zack Dvey-Aharon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2022
Decision Date	11/10/2022
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