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FDA 510(k)

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT

K-Number: K131240 · 2013-11-07

ApplicantCochlear Americas
Decision Date2013-11-07
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2013-11-07 under 510(k) number K131240. 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 COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT?

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT is a medical device that received FDA 510(k) clearance on 2013-11-07. The listed applicant is Cochlear Americas. The 510(k) number is K131240.

When did COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT receive FDA 510(k) clearance?

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT received FDA 510(k) clearance on 2013-11-07, under 510(k) number K131240.

Who is the listed applicant for COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT?

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

What is the FDA product code for COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT?

The FDA product code for COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT is LXB.

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Other records listing Cochlear Americas as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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