Resonance R16M
by M.R.S. SRL
Resonance R16M (4300104100) is a Class II device made by M.R.S. SRL, cleared under FDA 510(k) K031978 on 21 Jul 2003 and listed in FDA GUDID since 1 Sep 2025 (UDI-DI 08051597160099), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08051597160099 | Date1 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031978 | Date21 Jul 2003 | StatusActive |
Official records
- AccessGUDID record 08051597160099
- FDA 510(k) database K031978
Across registries
- FDA 510(k) K031978 decided 21 Jul 2003 Active
- FDA GUDID UDI-DI 08051597160099 listed 1 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K031978
- Listed FDA GUDID 08051597160099
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Resonance
- Generic name
- Impedance audiometer
- Model / Ref / Catalog
- R16M, 4300104100
- Primary DI / UDI-DI
- 08051597160099
- 510(k) Number
- FDA product code
- ETY
- GMDN term
- Impedance audiometer
- Device class
- Class II
- Regulation number
- 874.1090
- GUDID distribution status
- In Commercial Distribution
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