K033108 is an FDA 510(k) clearance for the VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Vivosonic, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on October 27, 2003, 27 days after receiving the submission on September 30, 2003.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K033108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | October 27, 2003 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWO - Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |