Cochlear P1340354
by Cochlear
Cochlear P1340354 is a Class II device made by Cochlear, cleared under FDA 510(k) K191921 on 15 Nov 2019 and listed in FDA GUDID since 23 Nov 2019 (UDI-DI 09321502046145), 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 | Number09321502046145 | Date23 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191921 | Date15 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 09321502046145
- FDA 510(k) database K191921
Across registries
- FDA 510(k) K191921 decided 15 Nov 2019 Active
- FDA GUDID UDI-DI 09321502046145 listed 23 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K191921
- Listed FDA GUDID 09321502046145
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cochlear
- Generic name
- Audiometric/hearing device software
- Model / Ref / Catalog
- P1340354
- Primary DI / UDI-DI
- 09321502046145
- 510(k) Number
- FDA product code
- PFO
- GMDN term
- Audiometric/hearing device software
- Device class
- Class II
- Regulation number
- 874.3340
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PFO (Active implantable bone conduction hearing system).
- Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments by Cochlear Americas
- Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit by Cochlear Americas
- BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) by Med-El Elektromedizinische Geraete GmbH
- BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) by Med-El Elektromedizinische Geraete GmbH
- Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS by Oticon Medical AB