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FDA 510(k)

Ponto Bone Anchored Hearing System

K-Number: K152820 · 2016-01-22

ApplicantOticon Medical AB
Decision Date2016-01-22
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ponto 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 2016-01-22 under 510(k) number K152820. 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 Ponto Bone Anchored Hearing System?

Ponto Bone Anchored Hearing System is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Oticon Medical AB. The 510(k) number is K152820.

When did Ponto Bone Anchored Hearing System receive FDA 510(k) clearance?

Ponto Bone Anchored Hearing System received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152820.

Who is the listed applicant for Ponto 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 Ponto Bone Anchored Hearing System?

The FDA product code for Ponto Bone Anchored Hearing System is MAH.

Related Clinical Trials

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.

NCT06976086Pediatric Expansion Study of the Sentio SystemACTIVE_NOT_RECRUITING

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.

K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSK213733Ponto 5 SuperPowerK211640Ponto 5 MiniK203807Ponto Bone Anchored Hearing System, MONO Surgery KitK190540Ponto 4K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

View all 7 devices →

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.

K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical ABK182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas

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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