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FDA 510(k)

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

K-Number: K153391 · 2016-06-16

ApplicantSophono, Inc.
Decision Date2016-06-16
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is the device name listed in this FDA 510(k) record. The listed applicant is Sophono, Inc.. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K153391. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Sophono, Inc.. The 510(k) number is K153391.

When did Sophono Bone Conduction Systems (S) Configuration and (M) Configuration receive FDA 510(k) clearance?

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration received FDA 510(k) clearance on 2016-06-16, under 510(k) number K153391.

Who is the listed applicant for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

The FDA 510(k) record lists Sophono, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

The FDA product code for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is LXB.

Related Devices (Code: LXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254296Ossiclear (Ossiclear System)SounductK260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)Zdeer Technology (Henan) Co., Ltd.K261256Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd.K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandCochlearK243041contact forte AlphaBhm-Tech Produktionsgesellschaft MbhK213733Ponto 5 SuperPowerOticon Medical AB

Official Source

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