Ponto 5 Mini
K-Number: K211640 · 2021-08-10
ApplicantOticon Medical AB
Decision Date2021-08-10
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Ponto 5 Mini is a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2021-08-10 under approval number K211640. 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 Mini?
Ponto 5 Mini is a medical device that received FDA 510(k) clearance on 2021-08-10. It is manufactured by Oticon Medical AB. The 510(k) number is K211640.
When was Ponto 5 Mini approved by the FDA?
Ponto 5 Mini received FDA 510(k) clearance on 2021-08-10, under approval number K211640.
What company makes Ponto 5 Mini?
Ponto 5 Mini is manufactured by Oticon Medical AB.
What is the FDA product code for Ponto 5 Mini?
The FDA product code for Ponto 5 Mini 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.