Identity
- Trade Name
- Integrity Computer FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- Laptop computer for use with the first generation of the Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) FDA UDI
- Model / Reference
- M500-C FDA UDI
- Description
- Laptop computer for use with the first generation of the Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908020130 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered
Integrity Computer by Vivosonic Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoacoustic emission system, battery-powered.
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
- Interacoustics — Interacoustics A/S · Class II
- TEOAE probe tips — Otodynamics · Class II
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 EP Headphones — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vivosonic Inc
Sources (1)
- FDA UDI 27a97f14-8f0d-4dfb-a8de-dddb316b02d5 34 fields · synced May 30, 2026