The following data is part of a premarket notification filed by Bloomfield Research And Development, Inc. with the FDA for Vox Companion.
| Device ID | K860992 |
| 510k Number | K860992 |
| Device Name: | VOX COMPANION |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | BLOOMFIELD RESEARCH AND DEVELOPMENT, INC. P.O. BOX 23980 Hilton Head, SC 29925 |
| Contact | David Lively |
| Correspondent | David Lively BLOOMFIELD RESEARCH AND DEVELOPMENT, INC. P.O. BOX 23980 Hilton Head, SC 29925 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-17 |
| Decision Date | 1986-05-02 |