FDA 510(k) Application Details - K233049

Device Classification Name	More FDA Info for this Device
510(K) Number	K233049
Device Name	TD 200« Automated TEE Probe Disinfector with TD-12« High-Level Disinfectant with QwikCheckÖ Chemical Indicator
Applicant	CS Medical LLC 2179 East Lyon Station Rd 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	09/25/2023
Decision Date	11/21/2023
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