K222057
- 510(k) number
- K222057
- Device name
- THERMOCLICK
- Applicant
- T&R BIOFAB CO., Ltd. KR
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2023-12-05
- Date received
- 2022-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K222057.pdf
Official FDA record: K222057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.