Identity
- Trade Name
- Resonance FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- SCREENING MIDDLE EAR ANALYZER FDA UDI
- Model / Reference
- R16M FDA UDI
- Description
- SCREENING MIDDLE EAR ANALYZER FDA UDI
Identifiers
- Catalog Number
- 4300104100 FDA UDI
- Primary DI / UDI-DI
- 08051597160099 FDA UDI
- 510(k) Number
- K031978 FDA UDI
- FDA Product Code
- ETY FDA UDI
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 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
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
No
FDA UDI
Category: Otoacoustic emission system, battery-poweredImpedance audiometer
Resonance by M.r.s. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031978 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
- M.r.s. Srl
Sources (1)
- FDA UDI cd2a91f4-a38f-4f21-86cb-1d08dc750783 35 fields · synced Jun 8, 2026