Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K-Number: K161671 · 2016-09-29
ApplicantOticon Medical AB
Decision Date2016-09-29
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2016-09-29 under approval number K161671. 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 3, Ponto 3 Power and Ponto 3 SuperPower?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Oticon Medical AB. The 510(k) number is K161671.
When was Ponto 3, Ponto 3 Power and Ponto 3 SuperPower approved by the FDA?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower received FDA 510(k) clearance on 2016-09-29, under approval number K161671.
What company makes Ponto 3, Ponto 3 Power and Ponto 3 SuperPower?
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is manufactured by Oticon Medical AB.
What is the FDA product code for Ponto 3, Ponto 3 Power and Ponto 3 SuperPower?
The FDA product code for Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is LXB.
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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.