K043396 is an FDA 510(k) clearance for the INTEGRITY, MODEL V500. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Vivosonic, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on January 24, 2005, 45 days after receiving the submission on December 10, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K043396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2004 |
| Decision Date | January 24, 2005 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GWJ - Stimulator, Auditory, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1900 |