Identity
- Trade Name
- Bio-logic FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- The ABaer Hearing Screening System performs automated objective hearing screening utilizing auditory brainstem responses (ABR) and/or otoacoustic emissions (OAE). FDA UDI
- Model / Reference
- ABaer FDA UDI
- Description
- The ABaer Hearing Screening System performs automated objective hearing screening utilizing auditory brainstem responses (ABR) and/or otoacoustic emissions (OAE). FDA UDI
Identifiers
- Catalog Number
- 580-ABAER2 FDA UDI
- Primary DI / UDI-DI
- 00382830001090 FDA UDI
- 510(k) Number
- K112247 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 400 Gram FDA UDIDepth — 1.7 Inch FDA UDIWidth — 4.0 Inch FDA UDIHeight — 7.6 Inch FDA UDI
Category: Evoked-potential audiometerAuditory stimulator
Bio-logic by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 9fdabf03-2b54-4205-bf77-e0d73dc252f0 38 fields · synced Jun 8, 2026