FDA 510(k)

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

Número K: K161671 · 2016-09-29

Data da decisão2016-09-29

Código do produtoLXB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K161671. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Oticon Medical AB. The 510(k) number is K161671.

When did Ponto 3, Ponto 3 Power and Ponto 3 SuperPower receive FDA 510(k) clearance?

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower received FDA 510(k) clearance on 2016-09-29, under 510(k) number K161671.

Who is the listed applicant for Ponto 3, Ponto 3 Power and Ponto 3 SuperPower?

The FDA 510(k) record lists Oticon Medical AB as the applicant. This does not by itself establish the device manufacturer.

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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