FDA 510(k) Application Details - K212830

Device Classification Name	Device, Cystometric, Hydraulic   More FDA Info for this Device
510(K) Number	K212830
Device Name	Device, Cystometric, Hydraulic
Applicant	SRS Medical 76 Treble Cove Road, Building #3 North Billerica, MA 01862 US Other 510(k) Applications for this Company
Contact	Lee Brody Other 510(k) Applications for this Contact
Regulation Number	876.1620   More FDA Info for this Regulation Number
Classification Product Code	FEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2021
Decision Date	12/21/2021
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