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FDA 510(k)

SOUNDBITE HEARING SYSTEM BY SONITUS

K-Number: K100649 · 2011-01-14

ApplicantSonitus Medical, Inc.
Decision Date2011-01-14
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SOUNDBITE HEARING SYSTEM BY SONITUS is the device name listed in this FDA 510(k) record. The listed applicant is Sonitus Medical, Inc.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K100649. 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 SOUNDBITE HEARING SYSTEM BY SONITUS?

SOUNDBITE HEARING SYSTEM BY SONITUS is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Sonitus Medical, Inc.. The 510(k) number is K100649.

When did SOUNDBITE HEARING SYSTEM BY SONITUS receive FDA 510(k) clearance?

SOUNDBITE HEARING SYSTEM BY SONITUS received FDA 510(k) clearance on 2011-01-14, under 510(k) number K100649.

Who is the listed applicant for SOUNDBITE HEARING SYSTEM BY SONITUS?

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

What is the FDA product code for SOUNDBITE HEARING SYSTEM BY SONITUS?

The FDA product code for SOUNDBITE HEARING SYSTEM BY SONITUS is LXB.

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Other records listing Sonitus Medical, 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.

K110831SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL

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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