FDA 510(k) Application Details - K240786

Device Classification Name	More FDA Info for this Device
510(K) Number	K240786
Device Name	AutoChamber
Applicant	HeartLung Corporation 2450 Holcombe Blvd Houston, TX 77021 US Other 510(k) Applications for this Company
Contact	Mark Scott Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2024
Decision Date	10/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review