FDA 510(k) Application Details - K243052

Device Classification Name	Cystometer, Electrical Recording   More FDA Info for this Device
510(K) Number	K243052
Device Name	Cystometer, Electrical Recording
Applicant	Bright Uro, Inc. 3 Goddard Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Dr. Roychowdhury Suranjan Other 510(k) Applications for this Contact
Regulation Number	876.1620   More FDA Info for this Regulation Number
Classification Product Code	EXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	03/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review