FDA 510(k) Application Details - K182891

Device Classification Name	More FDA Info for this Device
510(K) Number	K182891
Device Name	TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
Applicant	CS Medical L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 US Other 510(k) Applications for this Company
Contact	Kendall Ashe Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2018
Decision Date	04/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review