K241389
- 510(k) number
- K241389
- Device name
- Infrascanner Model 2500 (Model 2500)
- Applicant
- Infrascan, Inc. PA · US
- Product code
- OPT — Infrared Hematoma Detector
- Decision date
- 2024-12-12
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241389.pdf
Official FDA record: K241389
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.