CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
FDA 510(k) clearance K051305 · decided 2005-08-18
Clearance details
- K-number
- K051305
- Device name
- CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
- Applicant
- Cs Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-05-19
- Decision date
- 2005-08-18
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- PSW
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.