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FDA 510(k)

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

Número K: K153391 · 2016-06-16

RequerenteSophono, Inc.
Data da decisão2016-06-16
Código do produtoLXB
Comité consultivoEN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is the device name listed in this FDA 510(k) record. The listed applicant is Sophono, Inc.. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K153391. 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 Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Sophono, Inc.. The 510(k) number is K153391.

When did Sophono Bone Conduction Systems (S) Configuration and (M) Configuration receive FDA 510(k) clearance?

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration received FDA 510(k) clearance on 2016-06-16, under 510(k) number K153391.

Who is the listed applicant for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

The FDA 510(k) record lists Sophono, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

The FDA product code for Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is LXB.

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