OEC One ASD
K-Number: K240828 · 2024-12-27
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2024-12-27
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OEC One ASD is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2024-12-27 under approval number K240828. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OEC One ASD?
OEC One ASD is a medical device that received FDA 510(k) clearance on 2024-12-27. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K240828.
When was OEC One ASD approved by the FDA?
OEC One ASD received FDA 510(k) clearance on 2024-12-27, under approval number K240828.
What company makes OEC One ASD?
OEC One ASD is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for OEC One ASD?
The FDA product code for OEC One ASD is OXO.
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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.