Ponto 4
K-Number: K190540 · 2019-05-02
ApplicantOticon Medical AB
Decision Date2019-05-02
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Ponto 4 is a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2019-05-02 under approval number K190540. 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 4?
Ponto 4 is a medical device that received FDA 510(k) clearance on 2019-05-02. It is manufactured by Oticon Medical AB. The 510(k) number is K190540.
When was Ponto 4 approved by the FDA?
Ponto 4 received FDA 510(k) clearance on 2019-05-02, under approval number K190540.
What company makes Ponto 4?
Ponto 4 is manufactured by Oticon Medical AB.
What is the FDA product code for Ponto 4?
The FDA product code for Ponto 4 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.