The following data is part of a premarket notification filed by Mountain Precision Mfg. Ltd. Co. with the FDA for Nu-vois Battery Powered Artificial Larynx.
| Device ID | K934483 |
| 510k Number | K934483 |
| Device Name: | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | MOUNTAIN PRECISION MFG. LTD. CO. 10688 EXECUTIVE DR. P.O. BOX 4983 Boise, ID 83704 |
| Contact | Eugene J Breski |
| Correspondent | Eugene J Breski MOUNTAIN PRECISION MFG. LTD. CO. 10688 EXECUTIVE DR. P.O. BOX 4983 Boise, ID 83704 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-14 |
| Decision Date | 1994-03-16 |