INNOVO
K-Number: K192357 · 2020-01-16
ApplicantAtlantic Therapeutics, Ltd.
Decision Date2020-01-16
Product CodeQAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
INNOVO is a medical device manufactured by Atlantic Therapeutics, Ltd.. It received FDA 510(k) clearance on 2020-01-16 under approval 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. It is manufactured by Atlantic Therapeutics, Ltd.. The 510(k) number is K192357.
When was INNOVO approved by the FDA?
INNOVO received FDA 510(k) clearance on 2020-01-16, under approval number K192357.
What company makes INNOVO?
INNOVO is manufactured by Atlantic Therapeutics, Ltd..
What is the FDA product code for INNOVO?
The FDA product code for INNOVO is QAJ.
Related Devices (Code: QAJ)
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.