FDA 510(k) Application Details - K221203

Device Classification Name	More FDA Info for this Device
510(K) Number	K221203
Device Name	AHI System
Applicant	Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor, MI 48104 US Other 510(k) Applications for this Company
Contact	Jennifer Baird Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2022
Decision Date	07/14/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review