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FDA 510(k)

XOMED AUDIANT BONE CONDUCTOR

K-Number: K881382 · 1988-06-21

ApplicantXomed, Inc.
Decision Date1988-06-21
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XOMED AUDIANT BONE CONDUCTOR is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1988-06-21 under 510(k) number K881382. 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 XOMED AUDIANT BONE CONDUCTOR?

XOMED AUDIANT BONE CONDUCTOR is a medical device that received FDA 510(k) clearance on 1988-06-21. The listed applicant is Xomed, Inc.. The 510(k) number is K881382.

When did XOMED AUDIANT BONE CONDUCTOR receive FDA 510(k) clearance?

XOMED AUDIANT BONE CONDUCTOR received FDA 510(k) clearance on 1988-06-21, under 510(k) number K881382.

Who is the listed applicant for XOMED AUDIANT BONE CONDUCTOR?

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

What is the FDA product code for XOMED AUDIANT BONE CONDUCTOR?

The FDA product code for XOMED AUDIANT BONE CONDUCTOR is LXB.

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Other records listing Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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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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