FDA 510(k) Application Details - K221112

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K221112
Device Name	Computer, Diagnostic, Programmable
Applicant	Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Phuong Park 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	04/15/2022
Decision Date	08/17/2022
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