Integrity V500

Vivosonic Inc · Model V500 · UDI-DI 00627908020017

510(k) clearances

Adverse events

Recalls

Facilities

Description

Main handheld VivoLink unit for use with second generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024 A82 Amplitrode: DI 00627908020031 A90 VivoAmp: DI 00627908020048 B71W Bone Conductor: DI 00627908020055 ER-2-800 Insert Earphones: DI 00627908020062 ER-3A-800 Insert Earphones: DI 00627908020079 ER-3C-800 Insert Earphones: DI 00627908020086 H-800 EP Headphones: DI 00627908020093 H-801 EP Headphones: DI 00627908020109 P81-GP OAE Probe: DI 00627908020116 P81-UG OAE Probe: DI 00627908020123 Computer: DI 00627908020130

Recalls

Date	Firm	Reason
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16	Cardinal Health, Inc	GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Cor

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.