ILUMIEN System with AptiVue Software version D.3
K-Number: K192267 · 2019-12-17
ApplicantABBOTT MEDICAL
Decision Date2019-12-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ILUMIEN System with AptiVue Software version D.3 is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-12-17 under approval number K192267. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ILUMIEN System with AptiVue Software version D.3?
ILUMIEN System with AptiVue Software version D.3 is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K192267.
When was ILUMIEN System with AptiVue Software version D.3 approved by the FDA?
ILUMIEN System with AptiVue Software version D.3 received FDA 510(k) clearance on 2019-12-17, under approval number K192267.
What company makes ILUMIEN System with AptiVue Software version D.3?
ILUMIEN System with AptiVue Software version D.3 is manufactured by ABBOTT MEDICAL.
What is the FDA product code for ILUMIEN System with AptiVue Software version D.3?
The FDA product code for ILUMIEN System with AptiVue Software version D.3 is DQO.
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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.