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FDA 510(k)

OTOMAG BONE CONDUCATION HEARING SYSTEM

K-Number: K132189 · 2013-11-22

ApplicantSophono, Inc.
Decision Date2013-11-22
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOMAG BONE CONDUCATION HEARING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sophono, Inc.. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K132189. 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 OTOMAG BONE CONDUCATION HEARING SYSTEM?

OTOMAG BONE CONDUCATION HEARING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is Sophono, Inc.. The 510(k) number is K132189.

When did OTOMAG BONE CONDUCATION HEARING SYSTEM receive FDA 510(k) clearance?

OTOMAG BONE CONDUCATION HEARING SYSTEM received FDA 510(k) clearance on 2013-11-22, under 510(k) number K132189.

Who is the listed applicant for OTOMAG BONE CONDUCATION HEARING SYSTEM?

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 OTOMAG BONE CONDUCATION HEARING SYSTEM?

The FDA product code for OTOMAG BONE CONDUCATION HEARING SYSTEM is LXB.

Related Clinical Trials

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.

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Other records listing Sophono, Inc. as applicant

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.

K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationK123962OTOMAG BONE CONDUCTION HEARING SYSTEMK102199OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)K100193OTOMAG BONE CONDUCTION HEARING SYSTEM

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.

K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)Shokz Health Global LimitedK254296Ossiclear (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 Mbh

Official Source

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