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FDA 510(k)

INNOVO

K-Number: K192357 · 2020-01-16

ApplicantAtlantic Therapeutics, Ltd.
Decision Date2020-01-16
Product CodeQAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNOVO is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Therapeutics, Ltd.. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K192357. The device is classified under product code QAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVO?

INNOVO is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Atlantic Therapeutics, Ltd.. The 510(k) number is K192357.

When did INNOVO receive FDA 510(k) clearance?

INNOVO received FDA 510(k) clearance on 2020-01-16, under 510(k) number K192357.

Who is the listed applicant for INNOVO?

The FDA 510(k) record lists Atlantic Therapeutics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVO?

The FDA product code for INNOVO is QAJ.

Related Devices (Code: QAJ)

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.

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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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