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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovere Medical, Inc.. It received FDA 510(k) clearance on 2020-04-07 under 510(k) 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. The listed applicant is Innovere Medical, Inc.. The 510(k) number is K193218.

When did Innovision Audio receive FDA 510(k) clearance?

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

Who is the listed applicant for Innovision Audio?

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

What is the FDA product code for Innovision Audio?

The FDA product code for Innovision Audio is LNH.

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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