510(k) K843951
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1984
- Date Received
- October 9, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Tracking, For Monitoring Jaw Positions
- Device Class
- Class I
- Regulation Number
- 872.2060
- Review Panel
- DE
- Submission Type