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 a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2016-01-22 under approval 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. It is manufactured by Oticon Medical AB. The 510(k) number is K152820.
When was Ponto Bone Anchored Hearing System approved by the FDA?
Ponto Bone Anchored Hearing System received FDA 510(k) clearance on 2016-01-22, under approval number K152820.
What company makes Ponto Bone Anchored Hearing System?
Ponto Bone Anchored Hearing System is manufactured by Oticon Medical AB.
What is the FDA product code for Ponto Bone Anchored Hearing System?
The FDA product code for Ponto Bone Anchored Hearing System is MAH.
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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.