TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
FDA 510(k) clearance K233049 · decided 2023-11-21
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2023-09-25
- Decision date
- 2023-11-21
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- PSW
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Creedmoor, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.