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FDA 510(k)

Resoundant Acoustic Driver System

K-Number: K201389 · 2020-07-10

ApplicantResoundant, Inc.
Decision Date2020-07-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Resoundant Acoustic Driver System is a medical device manufactured by Resoundant, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval number K201389. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resoundant Acoustic Driver System?

Resoundant Acoustic Driver System is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Resoundant, Inc.. The 510(k) number is K201389.

When was Resoundant Acoustic Driver System approved by the FDA?

Resoundant Acoustic Driver System received FDA 510(k) clearance on 2020-07-10, under approval number K201389.

What company makes Resoundant Acoustic Driver System?

Resoundant Acoustic Driver System is manufactured by Resoundant, Inc..

What is the FDA product code for Resoundant Acoustic Driver System?

The FDA product code for Resoundant Acoustic Driver System is LNH.

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Other Devices by Resoundant, Inc.

K183193MREplus+ Software

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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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