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FDA 510(k)

OBC BONE ANCHORED HEARING SYSTEM

K-Number: K112053 · 2011-11-18

ApplicantOticon Medical AB
Decision Date2011-11-18
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OBC BONE ANCHORED HEARING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K112053. 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 OBC BONE ANCHORED HEARING SYSTEM?

OBC BONE ANCHORED HEARING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Oticon Medical AB. The 510(k) number is K112053.

When did OBC BONE ANCHORED HEARING SYSTEM receive FDA 510(k) clearance?

OBC BONE ANCHORED HEARING SYSTEM received FDA 510(k) clearance on 2011-11-18, under 510(k) number K112053.

Who is the listed applicant for OBC BONE ANCHORED HEARING SYSTEM?

The FDA 510(k) record lists Oticon Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBC BONE ANCHORED HEARING SYSTEM?

The FDA product code for OBC BONE ANCHORED HEARING SYSTEM is MAH.

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Other records listing Oticon Medical AB 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.

K261142Ponto 5 Mini; Ponto 5 SuperpowerK240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSK213733Ponto 5 SuperPowerK211640Ponto 5 MiniK203807Ponto Bone Anchored Hearing System, MONO Surgery KitK190540Ponto 4

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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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