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FDA 510(k)

NOBELPHARMA BONE ANCHORED HEARING AID

K-Number: K955713 · 1996-08-09

ApplicantNobelpharma USA, Inc.
Decision Date1996-08-09
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NOBELPHARMA BONE ANCHORED HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1996-08-09 under 510(k) number K955713. 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 NOBELPHARMA BONE ANCHORED HEARING AID?

NOBELPHARMA BONE ANCHORED HEARING AID is a medical device that received FDA 510(k) clearance on 1996-08-09. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K955713.

When did NOBELPHARMA BONE ANCHORED HEARING AID receive FDA 510(k) clearance?

NOBELPHARMA BONE ANCHORED HEARING AID received FDA 510(k) clearance on 1996-08-09, under 510(k) number K955713.

Who is the listed applicant for NOBELPHARMA BONE ANCHORED HEARING AID?

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

What is the FDA product code for NOBELPHARMA BONE ANCHORED HEARING AID?

The FDA product code for NOBELPHARMA BONE ANCHORED HEARING AID is LXB.

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Other records listing Nobelpharma USA, Inc. as applicant

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K984162BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USEK962403NOBLEPHARMA WIDE ACCESSORIESK962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTUREK96173617 ANGULATED ABUTMENTK961737CERA ONE ABUTMENT SYSTEMK961728MIRUSCONE ABUTMENT SYSTEM

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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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