K240466
- 510(k) number
- K240466
- Device name
- STARband 3D
- Applicant
- Orthomerica Products, Inc. FL · US
- Product code
- OAN — Orthosis, Cranial, Laser Scan
- Decision date
- 2024-03-15
- Date received
- 2024-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240466.pdf
Official FDA record: K240466
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.