510(k) K952218
K952218 is an FDA 510(k) premarket notification submitted by Bio-Research Associates, Inc. for the device "JT-3 ELECTROGNATHOGRAPH". The FDA issued a decision of Substantially Equivalent on September 21, 1995. The device falls under product code NFS (Device, Jaw Tracking, For Monitoring Jaw Positions), a Class I device regulated under 21 CFR 872.2060. Bio-Research Associates, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1995
- Date Received
- May 11, 1995
- 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