FDA 510(k) Application Details - K241243

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K241243
Device Name	Computer, Diagnostic, Programmable
Applicant	Centerline Biomedical, Inc. 10000 Cedar Ave Cleveland, OH 44106 US Other 510(k) Applications for this Company
Contact	Amanda Shade Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2024
Decision Date	07/24/2024
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