OEC One
K-Number: K182626 · 2018-11-16
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2018-11-16
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OEC One is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2018-11-16 under approval number K182626. 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?
OEC One is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K182626.
When was OEC One approved by the FDA?
OEC One received FDA 510(k) clearance on 2018-11-16, under approval number K182626.
What company makes OEC One?
OEC One is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for OEC One?
The FDA product code for OEC One 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.