K240463
- 510(k) number
- K240463
- Device name
- Slow Wave DS8 (SWDS802)
- Applicant
- Slow Wave, Inc. TX · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2024-06-04
- Date received
- 2024-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240463.pdf
Official FDA record: K240463
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.