The following data is part of a premarket notification filed by Monargue Intl. with the FDA for Teacher Tm.
| Device ID | K851655 |
| 510k Number | K851655 |
| Device Name: | TEACHER TM |
| Classification | Hearing Aid, Tactile |
| Applicant | MONARGUE INTL. 21757 DEVONSHIRE STREET, SUITE 12A CHATSWORTH, CA 91311 |
| Contact | JOHN A ANDROSS |
| Correspondent | JOHN A ANDROSS MONARGUE INTL. 21757 DEVONSHIRE STREET, SUITE 12A CHATSWORTH, CA 91311 |
| Product Code | LRA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-22 |
| Decision Date | 1985-06-20 |