The following data is part of a premarket notification filed by Bfw Laboratories, Inc. with the FDA for Bfw Voice Generator.
| Device ID | K851462 |
| 510k Number | K851462 |
| Device Name: | BFW VOICE GENERATOR |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | BFW LABORATORIES, INC. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Contact | Michael W Walsh |
| Correspondent | Michael W Walsh BFW LABORATORIES, INC. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-12 |
| Decision Date | 1985-05-28 |