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FDA 510(k)

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

K-Number: K153391 · 2016-06-16

ApplicantSophono, Inc.
Decision Date2016-06-16
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is a medical device manufactured by Sophono, Inc.. It received FDA 510(k) clearance on 2016-06-16 under approval number K153391. 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 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. It is manufactured by Sophono, Inc.. The 510(k) number is K153391.

When was Sophono Bone Conduction Systems (S) Configuration and (M) Configuration approved by the FDA?

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

What company makes Sophono Bone Conduction Systems (S) Configuration and (M) Configuration?

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is manufactured by Sophono, Inc..

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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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.

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