510(k) K843951
K843951 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIROGNATHOGRAPH". The FDA issued a decision of Substantially Equivalent on November 14, 1984. The device falls under product code NFS (Device, Jaw Tracking, For Monitoring Jaw Positions), a Class I device regulated under 21 CFR 872.2060. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
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