K244056
- 510(k) number
- K244056
- Device name
- DOC Band 3D
- Applicant
- Cranial Technologies, Inc. AZ · US
- Product code
- OAN — Orthosis, Cranial, Laser Scan
- Decision date
- 2025-03-17
- Date received
- 2024-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K244056.pdf
Official FDA record: K244056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.