510(k) K240463
K240463 is an FDA 510(k) premarket notification submitted by Slow Wave, Inc. for the device "Slow Wave DS8 (SWDS802)". The FDA issued a decision of Substantially Equivalent on June 4, 2024. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Slow Wave, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2024
- Date Received
- February 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type