K242954
- 510(k) number
- K242954
- Device name
- Integrity V500 (Integrity, Integrity with VEMP)
- Applicant
- Vivosonic, Inc. CA
- Product code
- GWJ — Stimulator, Auditory, Evoked Response
- Decision date
- 2024-12-19
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242954.pdf
Official FDA record: K242954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.