FDA 510(k) Application Details - K190106

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K190106
Device Name	Computer, Diagnostic, Programmable
Applicant	Centerline Biomedical, Inc. 10000 Cedar Ave Cleveland, OH 44106 US Other 510(k) Applications for this Company
Contact	Vikash Goel 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	01/22/2019
Decision Date	06/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review