The following data is part of a premarket notification filed by Manico with the FDA for Tbi Trainer.
| Device ID | K840837 |
| 510k Number | K840837 |
| Device Name: | TBI TRAINER |
| Classification | Attachment, Binocular, For Endoscope |
| Applicant | MANICO 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FEJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1985-03-25 |