The following data is part of a premarket notification filed by Sonic Systems, Inc. with the FDA for Vibro-com Communicator #8827.
| Device ID | K813057 |
| 510k Number | K813057 |
| Device Name: | VIBRO-COM COMMUNICATOR #8827 |
| Classification | Hearing Aid, Tactile |
| Applicant | SONIC SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 | 1981-10-29 |
| Decision Date | 1981-12-02 |