The following data is part of a premarket notification filed by Vivosonic, Inc. with the FDA for Vivosonic Neuroscreen.
| Device ID | K080060 |
| 510k Number | K080060 |
| Device Name: | VIVOSONIC NEUROSCREEN |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | VIVOSONIC, INC. 120-5525 EGLINTON AVENUE WEST Toronto, On, CA M9c 5k5 |
| Contact | Amjad Rana |
| Correspondent | Amjad Rana VIVOSONIC, INC. 120-5525 EGLINTON AVENUE WEST Toronto, On, CA M9c 5k5 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-09 |
| Decision Date | 2008-04-04 |