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Scout Sport Otoacoustic Emissions Measurement System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Scout Sport Otoacoustic Emissions Measurement System FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- The Scout Sport Otoacoustix Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE input/output (I/O) tests. FDA UDI
- Model / Reference
- Scout Sport FDA UDI
- Description
- The Scout Sport Otoacoustix Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE input/output (I/O) tests. FDA UDI
Identifiers
- Catalog Number
- 580-SP2191 FDA UDI
- Primary DI / UDI-DI
- 00382830001618 FDA UDI
- 510(k) Number
- K121512 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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 audiometer
Scout Sport Otoacoustic Emissions Measurement System 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
K121512 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 071f8764-a825-428f-9e90-e9babd471b44 37 fields · synced May 30, 2026