Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Tone audiometer, automated FDA UDI
- Device Name
- Welch Allyn MicroTymp-3 Printer/Charger Base; 100-240 V, 50-60 Hz AC, Lithium-Ion (#72910) Battery; IEC Plug Type-B FDA UDI
- Model / Reference
- 901002 FDA UDI
- Description
- Welch Allyn MicroTymp-3 Printer/Charger Base; 100-240 V, 50-60 Hz AC, Lithium-Ion (#72910) Battery; IEC Plug Type-B FDA UDI
Identifiers
- Catalog Number
- 71170 FDA UDI
- Primary DI / UDI-DI
- 00732094140507 FDA UDI
- 510(k) Number
- K861516 FDA UDI
- FDA Product Code
- ETY FDA UDI
- GMDN Term
- Tone audiometer, automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K861516 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI ddd7dd0c-d9b1-4728-b7a1-826d516669ca 37 fields · synced Jun 1, 2026