Identity
- Trade Name
- Bio-logic FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing disorders. FDA UDI
- Model / Reference
- Navigator Pro FDA UDI
- Description
- The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing disorders. FDA UDI
Identifiers
- Catalog Number
- 580-NAVPR2 FDA UDI
- Primary DI / UDI-DI
- 00382830053181 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
No
FDA UDI
Category: Evoked-potential audiometer
Bio-logic by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031009 also covers:
K073626 also covers:
K083371 also covers:
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
- Natus Medical Incorporated
Sources (1)
- FDA UDI 426ab753-ce0e-44d0-ac9c-91282d1f806e 37 fields · synced May 30, 2026