FDA 510(k) Application Details - DEN200022

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200022
Device Name	Analytic for Hemodynamic Instability (AHI)
Applicant	Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor, MI 48104 US Other 510(k) Applications for this Company
Contact	Jennifer A 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	04/03/2020
Decision Date	03/01/2021
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review