Identity
- Trade Name
- Etymotic Research FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- ER1-14A foam ear tips with ER7-14C probe tubes FDA UDI
- Model / Reference
- ER7-14C-EM FDA UDI
- Description
- ER1-14A foam ear tips with ER7-14C probe tubes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846430004597 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
- Not 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
Etymotic Research by Etymotic Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 bb070c51-fc9a-4f72-8964-544e5d4f806b 35 fields · synced May 30, 2026