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FDA 510(k)

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE

K-Number: K984162 · 1999-06-28

ApplicantNobelpharma USA, Inc.
Decision Date1999-06-28
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE 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 1999-06-28 under 510(k) number K984162. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE?

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE is a medical device that received FDA 510(k) clearance on 1999-06-28. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K984162.

When did BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE receive FDA 510(k) clearance?

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE received FDA 510(k) clearance on 1999-06-28, under 510(k) number K984162.

Who is the listed applicant for BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE?

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 BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE?

The FDA product code for BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE is MAH.

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Other records listing Nobelpharma USA, 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.

K962403NOBLEPHARMA WIDE ACCESSORIESK955713NOBELPHARMA BONE ANCHORED HEARING AIDK962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTUREK96173617 ANGULATED ABUTMENTK961737CERA ONE ABUTMENT SYSTEMK961728MIRUSCONE ABUTMENT SYSTEM

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Related Devices (Code: MAH)

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.

K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical ABK203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical ABK182116BA310 Abutment, BIA310 Implant/AbutmentCochlear AmericasK152820Ponto Bone Anchored Hearing SystemOticon Medical ABK121317COCHLEAR BAHA IMPLANT SYSTEMCochlear AmericasK121228PONTO BONE ANCHORED HEARING SYSTEMOticon Medical AB

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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