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K233049

TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator

510(k) number
K233049
Device name
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
Applicant
Cs Medical, LLC NC · US
Product code
PSW — High Level Disinfection Reprocessing Instrument For
Decision date
2023-11-21
Date received
2023-09-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K233049.pdf

Official FDA record: K233049
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.