Identifiers
- 510(k) Number
- K043396 FDA 510(k)
- FDA Product Code
- GWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1900 FDA 510(k)
- Regulation Number
- 882.1900 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Integrity, Model V500 is an auditory evoked response stimulator device. It is designed to generate auditory stimuli for neurological testing purposes. The device is classified under product code GWJ and is intended for use in neurology applications.
The Integrity, Model V500 is manufactured by Vivosonic Inc and received FDA 510(k) clearance with number K043396 on January 24, 2005. It is a Class II device that was reviewed by the Neurology advisory committee. The device is supplied with various model numbers and registration numbers as specified in the device data.
Frequently asked questions
What is the Integrity, Model V500 used for?
The Integrity, Model V500 is designed to generate auditory stimuli for neurological testing purposes, specifically for use in neurology applications as an auditory evoked response stimulator device.
How is the Integrity, Model V500 supplied and identified?
The device is supplied with various model numbers and registration numbers as specified in the device data, including multiple FEI numbers and registration numbers associated with Vivosonic Inc's listings.
What regulatory pathway was used for the Integrity, Model V500?
The Integrity, Model V500 received FDA 510(k) clearance with number K043396 on January 24, 2005, and was classified as a Class II device reviewed by the Neurology advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043396 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vivosonic Inc
- FDA Applicant
- Vivosonic, Inc.
Sources (1)
- FDA 510(k) K043396 24 fields · synced Sep 23, 2026