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510(k) K243041

Device
contact forte Alpha
Applicant
Bhm-Tech Produktionsgesellschaft Mbh
510(k) number
K243041
Product code
LXB
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-25
Date received
2024-09-27
Regulation
874.3302
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
Markus Hirtzi
Address
Grafenschachen 242 Grafenschachen AT 7423 7423

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K190540Ponto 4Oticon Medical AB2019-05-02
K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH2018-04-27
K171088Cochlear Baha SoundArcCochlear Americas2017-06-07
K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB2016-09-29
K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.2016-06-16
K161123Baha 5 Power Sound ProcessorCochlear Americas2016-05-20
K153245Baha 5 Super Power Sound ProcessorCochlear Americas2016-03-02
K150751Cordelle II Sound ProcessorCochlear Americas2015-07-22
K142907Baha 5 Sound ProcessorCochlear Americas2015-03-25
K132775PONTO PLUS AND PONTO PLUS POWEROticon Medical AB2013-12-09