K233049
- 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.