The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for Jt-3 Electrognathograph.
| Device ID | K952218 |
| 510k Number | K952218 |
| Device Name: | JT-3 ELECTROGNATHOGRAPH |
| Classification | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Contact | John C Radke |
| Correspondent | John C Radke BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Product Code | NFS |
| CFR Regulation Number | 872.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-11 |
| Decision Date | 1995-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003499917 | K952218 | 000 |