Identity
- Trade Name
- Integrity V500 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Main handheld VivoLink unit for use with the first 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 can be used with the first generation Integrity V500 system: A61 Amplitrode: DI 00627908010025 B71-10 Bone Conductor: DI 00627908010032 ER-3A-ABR Insert Earphones: DI 00627908010049 HDA 300 EP Headphones: DI 00627908010056 P40-GP OAE Probe: DI 00627908010063 P40-UG OAE Probe: DI 00627908010070 FDA UDI
- Model / Reference
- V500 FDA UDI
- Description
- Main handheld VivoLink unit for use with the first 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 can be used with the first generation Integrity V500 system: A61 Amplitrode: DI 00627908010025 B71-10 Bone Conductor: DI 00627908010032 ER-3A-ABR Insert Earphones: DI 00627908010049 HDA 300 EP Headphones: DI 00627908010056 P40-GP OAE Probe: DI 00627908010063 P40-UG OAE Probe: DI 00627908010070 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908010018 FDA UDI
- 510(k) Number
- K043396 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
Integrity V500 by Vivosonic Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K043396 also covers:
- Bone Conductor — Vivosonic Inc
- ECochG Adapters — Vivosonic Inc
- EP Headphones — Vivosonic Inc
- EarDome — Vivosonic Inc
- Integrity Amplitrode — Vivosonic Inc
- Integrity Amplitrode — Vivosonic Inc
- Integrity Amplitrode — Vivosonic Inc
- Integrity Bone Conductor — Vivosonic Inc
- Integrity Bone Conductor — Vivosonic Inc
- Integrity CV-Amp — Vivosonic Inc
- Integrity Computer — Vivosonic Inc
- Integrity EP Headphones — Vivosonic Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vivosonic Inc
Sources (1)
- FDA UDI 1b19458a-cd17-40aa-a8ff-2ef6d6491785 34 fields · synced May 30, 2026