The following data is part of a premarket notification filed by Rsq, Llc. with the FDA for Visivox, Model V-2.
| Device ID | K982396 |
| 510k Number | K982396 |
| Device Name: | VISIVOX, MODEL V-2 |
| Classification | Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) |
| Applicant | RSQ, LLC. 636 WELLESLEY DR. Claremont, CA 91711 -3427 |
| Contact | Doris Drucker |
| Correspondent | Doris Drucker RSQ, LLC. 636 WELLESLEY DR. Claremont, CA 91711 -3427 |
| Product Code | LEZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-09 |
| Decision Date | 1998-09-14 |
| Summary: | summary |