Ponto 5 SuperPower
K-Number: K213733 · 2021-12-16
ApplicantOticon Medical AB
Decision Date2021-12-16
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Ponto 5 SuperPower is a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2021-12-16 under approval number K213733. 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 Ponto 5 SuperPower?
Ponto 5 SuperPower is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Oticon Medical AB. The 510(k) number is K213733.
When was Ponto 5 SuperPower approved by the FDA?
Ponto 5 SuperPower received FDA 510(k) clearance on 2021-12-16, under approval number K213733.
What company makes Ponto 5 SuperPower?
Ponto 5 SuperPower is manufactured by Oticon Medical AB.
What is the FDA product code for Ponto 5 SuperPower?
The FDA product code for Ponto 5 SuperPower is LXB.
Other Devices by Oticon Medical AB
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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.