CLISIS SYSTEMS, Discovery RF180
K-Number: K213081 · 2021-10-26
ApplicantGeneral Medical Merate S.P.A
Decision Date2021-10-26
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CLISIS SYSTEMS, Discovery RF180 is a medical device manufactured by General Medical Merate S.P.A. It received FDA 510(k) clearance on 2021-10-26 under approval number K213081. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CLISIS SYSTEMS, Discovery RF180?
CLISIS SYSTEMS, Discovery RF180 is a medical device that received FDA 510(k) clearance on 2021-10-26. It is manufactured by General Medical Merate S.P.A. The 510(k) number is K213081.
When was CLISIS SYSTEMS, Discovery RF180 approved by the FDA?
CLISIS SYSTEMS, Discovery RF180 received FDA 510(k) clearance on 2021-10-26, under approval number K213081.
What company makes CLISIS SYSTEMS, Discovery RF180?
CLISIS SYSTEMS, Discovery RF180 is manufactured by General Medical Merate S.P.A.
What is the FDA product code for CLISIS SYSTEMS, Discovery RF180?
The FDA product code for CLISIS SYSTEMS, Discovery RF180 is IZF.
Other Devices by General Medical Merate S.P.A
Related Devices (Code: IZF)
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.