The following data is part of a premarket notification filed by Vivosonic, Inc. with the FDA for Vivo 200 Dps Vivoscan Version 2.0 Oae Audiometer.
| Device ID | K033108 |
| 510k Number | K033108 |
| Device Name: | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER |
| Classification | Audiometer |
| Applicant | VIVOSONIC, INC. 56 ABERFOYLE CRESCENT SUITE 620 Toronto, On, CA M8x 2w4 |
| Contact | Yuri Sokolov |
| Correspondent | Yuri Sokolov VIVOSONIC, INC. 56 ABERFOYLE CRESCENT SUITE 620 Toronto, On, CA M8x 2w4 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-10-27 |
| Summary: | summary |