Clearance Summary
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator received FDA 510(k) clearance under submission number K233049, sponsored by Cs Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-11-21.
- Submission: K233049
- Applicant / Sponsor: Cs Medical, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2023-11-21
Classification & Regulation
This clearance is catalogued under FDA product code PSW and 21 CFR 892.1570, within the Radiology review panel as a Class II device.