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USBLite Cart Sound-Output-Electrode Box w 10D Grounded
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- USBLite Cart Sound-Output-Electrode Box w 10D Grounded FDA UDI
- Generic Name
- Otoacoustic emission system, line-powered FDA UDI
- Model / Reference
- M011202G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020754 FDA UDI
- 510(k) Number
- K090579 FDA UDI
- FDA Product Code
- GWJ FDA UDIEWO FDA UDI
- GMDN Term
- Otoacoustic emission system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 FDA UDI874.1050 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
Yes
FDA UDI
Category: Evoked-potential graphic recording systemOtoacoustic emission system, line-powered
USBLite Cart Sound-Output-Electrode Box w 10D Grounded by Intelligent Hearing Systems Corp. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K090579 also covers:
- Aria — Intelligent Hearing Systems Corp.
- Screener Cart — Intelligent Hearing Systems Corp.
- Screener Cart (TUV Listed) — Intelligent Hearing Systems Corp.
- SmartScreener-Plus2 AEP Module — Intelligent Hearing Systems Corp.
- SmartScreener-Plus2 OAE Module — Intelligent Hearing Systems Corp.
- SmartScreener-Plus2 Screener Launch — Intelligent Hearing Systems Corp.
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
- Intelligent Hearing Systems Corp.
Sources (1)
- FDA UDI e5915cda-2a04-4286-b78a-e21010a77bc0 33 fields · synced Jun 8, 2026