The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear Venti--voice.
| Device ID | K834555 |
| 510k Number | K834555 |
| Device Name: | BEAR VENTI--VOICE |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-27 |
| Decision Date | 1984-01-24 |