K003364 is an FDA 510(k) clearance for the VIVO 200 DPS VIVOSCAN. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Vivosonic, Inc. (Stamford, US). The FDA issued a Cleared decision on July 18, 2001, 264 days after receiving the submission on October 27, 2000.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K003364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2000 |
| Decision Date | July 18, 2001 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| 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 |