AMICUS Separator System
K-Number: K200530 · 2020-09-11
ApplicantFresenius Kabi AG
Decision Date2020-09-11
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
AMICUS Separator System is a medical device manufactured by Fresenius Kabi AG. It received FDA 510(k) clearance on 2020-09-11 under approval number K200530. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AMICUS Separator System?
AMICUS Separator System is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Fresenius Kabi AG. The 510(k) number is K200530.
When was AMICUS Separator System approved by the FDA?
AMICUS Separator System received FDA 510(k) clearance on 2020-09-11, under approval number K200530.
What company makes AMICUS Separator System?
AMICUS Separator System is manufactured by Fresenius Kabi AG.
What is the FDA product code for AMICUS Separator System?
The FDA product code for AMICUS Separator System is GKT.
Other Devices by Fresenius Kabi AG
Related Devices (Code: GKT)
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.