K240220
- 510(k) number
- K240220
- Device name
- Aulisa Temperature Module (TM0002)
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc. TW
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2024-09-27
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K240220.pdf
Official FDA record: K240220
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.