510(k) K172460
- Device
- ADHEAR System
- Applicant
- MED-EL Elektromedizinische Geraete GmbH
- 510(k) number
- K172460
- Product code
- LXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-27
- Date received
- 2017-08-14
- Regulation
- 874.3300
- Classification name
- Hearing Aid, Bone Conduction
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elizabeth Gfoeller
- Address
- Fuerstenweg 77a Innsbruck AT 6020 6020
FDA Registration Numbers#
- 3005216725
- 3005820796
- 3014579188
- 3012593436
- 3007689689
- 9612468
- 3006405073
- 3003477135
- 3014990990
- 3027588012
- 3007275459
- 8031010
- 3003847101
- 3013177549
- 3007743836
- 3007367732
- 9613646
- 3009092818
- 3010376846
- 3009632672
- 3009307953
- 3005900820
- 3005150478
- 9616024
- 3018094310
- 3020283264
- 9710014
- 3034209804
- 1045254
- 3010097171
Source Documents#
Other 510(k) Records For Product Code LXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | 2025-05-29 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | 2021-09-29 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | 2021-02-23 |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016-09-29 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016-06-16 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016-03-02 |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015-07-22 |
| K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015-03-25 |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Oticon Medical AB | 2013-12-09 |
Legacy Summary#
summary
FDA Review#
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