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FDA 510(k)

Innovision Audio

K-Number: K193218 · 2020-04-07

ApplicantInnovere Medical, Inc.
Decision Date2020-04-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Innovision Audio is a medical device manufactured by Innovere Medical, Inc.. It received FDA 510(k) clearance on 2020-04-07 under approval number K193218. 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 Innovision Audio?

Innovision Audio is a medical device that received FDA 510(k) clearance on 2020-04-07. It is manufactured by Innovere Medical, Inc.. The 510(k) number is K193218.

When was Innovision Audio approved by the FDA?

Innovision Audio received FDA 510(k) clearance on 2020-04-07, under approval number K193218.

What company makes Innovision Audio?

Innovision Audio is manufactured by Innovere Medical, Inc..

What is the FDA product code for Innovision Audio?

The FDA product code for Innovision Audio is LNH.

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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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