Identity
- Trade Name
- Integrity Software FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240 FDA UDI
- Model / Reference
- SWA001 FDA UDI
- Description
- Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908090010 FDA UDI
- 510(k) Number
- K043396 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Otoacoustic emission system, battery-powered 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
Integrity Software 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 8f9d5de9-f4b4-462f-b011-a5cfa2e40b40 34 fields · synced May 31, 2026