Stela Automix System
K-Number: K222581 · 2022-10-28
ApplicantSdi Limited
Decision Date2022-10-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Stela Automix System is a medical device manufactured by Sdi Limited. It received FDA 510(k) clearance on 2022-10-28 under approval number K222581. 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 Stela Automix System?
Stela Automix System is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Sdi Limited. The 510(k) number is K222581.
When was Stela Automix System approved by the FDA?
Stela Automix System received FDA 510(k) clearance on 2022-10-28, under approval number K222581.
What company makes Stela Automix System?
Stela Automix System is manufactured by Sdi Limited.
What is the FDA product code for Stela Automix System?
The FDA product code for Stela Automix System is EBF.
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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.