Infinix Universal Composite
K-Number: K182921 · 2019-09-13
ApplicantNobio , Ltd.
Decision Date2019-09-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Infinix Universal Composite is a medical device manufactured by Nobio , Ltd.. It received FDA 510(k) clearance on 2019-09-13 under approval number K182921. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infinix Universal Composite?
Infinix Universal Composite is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Nobio , Ltd.. The 510(k) number is K182921.
When was Infinix Universal Composite approved by the FDA?
Infinix Universal Composite received FDA 510(k) clearance on 2019-09-13, under approval number K182921.
What company makes Infinix Universal Composite?
Infinix Universal Composite is manufactured by Nobio , Ltd..
What is the FDA product code for Infinix Universal Composite?
The FDA product code for Infinix Universal Composite is EBF.
Related Clinical Trials
Other Devices by Nobio , Ltd.
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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.