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FDA 510(k)

HEADBAND FOR BAHA

K-Number: K002913 · 2000-10-17

ApplicantEntific Medical Systems, Inc.
Decision Date2000-10-17
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEADBAND FOR BAHA 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 2000-10-17 under 510(k) number K002913. 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 HEADBAND FOR BAHA?

HEADBAND FOR BAHA is a medical device that received FDA 510(k) clearance on 2000-10-17. The listed applicant is Entific Medical Systems, Inc.. The 510(k) number is K002913.

When did HEADBAND FOR BAHA receive FDA 510(k) clearance?

HEADBAND FOR BAHA received FDA 510(k) clearance on 2000-10-17, under 510(k) number K002913.

Who is the listed applicant for HEADBAND FOR BAHA?

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 HEADBAND FOR BAHA?

The FDA product code for HEADBAND FOR BAHA 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)K011438BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.K992872BRANEMARK 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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