ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
FDA 510(k) clearance K202461 · decided 2022-08-12
Clearance details
- K-number
- K202461
- Device name
- ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
- Applicant
- Smisson-Cartledge Biomedical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-08-27
- Decision date
- 2022-08-12
- Days to decision
- 715 days
- Clearance type
- Traditional
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Macon, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.