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FDA 510(k)

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

K-Number: K011438 · 2001-07-23

ApplicantEntific Medical Systems, Inc.
Decision Date2001-07-23
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. is the device name listed in this FDA 510(k) record. The listed applicant is Entific Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-07-23 under 510(k) number K011438. 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 BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.?

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is Entific Medical Systems, Inc.. The 510(k) number is K011438.

When did BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. receive FDA 510(k) clearance?

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. received FDA 510(k) clearance on 2001-07-23, under 510(k) number K011438.

Who is the listed applicant for BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.?

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

What is the FDA product code for BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.?

The FDA product code for BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. is LXB.

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Other records listing Entific Medical Systems, 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.

K042017BAHA DIVINOK021837BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)K002913HEADBAND FOR BAHAK992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II

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

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