The following data is part of a premarket notification filed by Vivosonic, Inc. with the FDA for Vivo 200 Dps Vivoscan.
| Device ID | K003364 |
| 510k Number | K003364 |
| Device Name: | VIVO 200 DPS VIVOSCAN |
| Classification | Audiometer |
| Applicant | VIVOSONIC, INC. 1151 HOPE ST. Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen VIVOSONIC, INC. 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-27 |
| Decision Date | 2001-07-18 |