FDA 510(k)

Lyra

K-Number: K191372 · 2019-07-15

Decision Date2019-07-15

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Lyra is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2019-07-15 under 510(k) number K191372. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lyra?

Lyra is a medical device that received FDA 510(k) clearance on 2019-07-15. The listed applicant is Interacoustics A/S. The 510(k) number is K191372.

When did Lyra receive FDA 510(k) clearance?

Lyra received FDA 510(k) clearance on 2019-07-15, under 510(k) number K191372.

Who is the listed applicant for Lyra?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lyra?

The FDA product code for Lyra is EWO.

Other records listing Interacoustics A/S as applicant

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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.