Identity
- Trade Name
- Etymotic Research FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- ER7C series B Pre-Amplifier FDA UDI
- Model / Reference
- ER7C Pre-Amp FDA UDI
- Description
- ER7C series B Pre-Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846430004948 FDA UDI
- 510(k) Number
- K861113 FDA UDI
- FDA Product Code
- ETW FDA UDI
- GMDN Term
- Audiometric/hearing aid tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3310 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: Audiometric/hearing aid tester
Etymotic Research by Etymotic Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing aid tester.
- Audioscan — Etymonic Design Incorporated · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- Audioscan — Etymonic Design Incorporated · Class II
- Unity 4 / Measure — Auditdata A/S · Class II
- Unity 4 — Auditdata A/S · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
Cleared under the same submission
K861113 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
- Etymotic Research, Inc.
Sources (1)
- FDA UDI cd962a3b-b541-40fe-9330-1eac6c1b9481 34 fields · synced May 30, 2026