Identity
- Trade Name
- Bio-Logic Scout Sport FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Scout is a PC-based measurement system that performs otoacoustic emissions tests. Using a combination of hardware and software, each system produces a controlled acoustic signal in the ear canal and measures the resulting otoacoustic emission that is generated by outer hair cells in the cochlea. The system collects and averages data samples until specified measurement parameters are achieved. FDA UDI
- Model / Reference
- 580-SPBOX1001 FDA UDI
- Description
- Scout is a PC-based measurement system that performs otoacoustic emissions tests. Using a combination of hardware and software, each system produces a controlled acoustic signal in the ear canal and measures the resulting otoacoustic emission that is generated by outer hair cells in the cochlea. The system collects and averages data samples until specified measurement parameters are achieved. FDA UDI
Identifiers
- Catalog Number
- 580-SPBOX1001 FDA UDI
- Primary DI / UDI-DI
- 00382830055031 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
Yes
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 Scout Sport 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 34a9d2b2-f10c-4359-9107-c94ed27ff98e 37 fields · synced Jun 6, 2026