FDA 510(k) Application Details - DEN210006

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210006
Device Name	Hemolung Respiratory Assist System
Applicant	ALung Technologies, Inc. 2500 Jane Street, Suite 1 Pittsburgh, PA 15203 US Other 510(k) Applications for this Company
Contact	Joe Argyros Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2021
Decision Date	11/13/2021
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