Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K-Number: K190816 · 2019-11-19
Decision Date2019-11-19
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is a medical device manufactured by Avenir Performance Europeenne Medical (Apem). It received FDA 510(k) clearance on 2019-11-19 under approval number K190816. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vial Adapter Ø20 mm , Vial Adapter Ø13 mm?
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is a medical device that received FDA 510(k) clearance on 2019-11-19. It is manufactured by Avenir Performance Europeenne Medical (Apem). The 510(k) number is K190816.
When was Vial Adapter Ø20 mm , Vial Adapter Ø13 mm approved by the FDA?
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm received FDA 510(k) clearance on 2019-11-19, under approval number K190816.
What company makes Vial Adapter Ø20 mm , Vial Adapter Ø13 mm?
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is manufactured by Avenir Performance Europeenne Medical (Apem).
What is the FDA product code for Vial Adapter Ø20 mm , Vial Adapter Ø13 mm?
The FDA product code for Vial Adapter Ø20 mm , Vial Adapter Ø13 mm is LHI.
Other Devices by Avenir Performance Europeenne Medical (Apem)
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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.