Identity
- Trade Name
- Etymotic Research FDA UDI
- Generic Name
- Otoacoustic emission system, battery-powered FDA UDI
- Device Name
- 10B+ Amplifier FDA UDI
- Model / Reference
- ER10B+ AMP FDA UDI
- Description
- 10B+ Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846430004900 FDA UDI
- 510(k) Number
- K930553 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Otoacoustic emission system, battery-powered 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
Yes
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: Otoacoustic emission system, battery-powered
Etymotic Research by Etymotic Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K930553 also covers:
- ER-1 — ETYMOTIC RESEARCH, INC.
- ER-1 — ETYMOTIC RESEARCH, INC.
- ER-2 — ETYMOTIC RESEARCH, INC.
- ER-2 — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Etymotic Research — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
- Single Use Eartip — ETYMOTIC RESEARCH, INC.
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
- Etymotic Research, Inc.
Sources (1)
- FDA UDI f2fe18ea-384b-4a32-8a9d-f797b1484f2b 34 fields · synced May 31, 2026