The following data is part of a premarket notification filed by Companion Products Intl. with the FDA for Companion Speech Aid, Model 160.
| Device ID | K910819 |
| 510k Number | K910819 |
| Device Name: | COMPANION SPEECH AID, MODEL 160 |
| Classification | System, Communication, Powered |
| Applicant | COMPANION PRODUCTS INTL. P.O. BOX 13133 Coyote, CA 95013 |
| Contact | Robert W Langstroth |
| Correspondent | Robert W Langstroth COMPANION PRODUCTS INTL. P.O. BOX 13133 Coyote, CA 95013 |
| Product Code | ILQ |
| CFR Regulation Number | 890.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-03-07 |