OEC Elite MiniView
K-Number: K171800 · 2017-07-12
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2017-07-12
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OEC Elite MiniView is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-07-12 under approval number K171800. 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 Elite MiniView?
OEC Elite MiniView is a medical device that received FDA 510(k) clearance on 2017-07-12. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K171800.
When was OEC Elite MiniView approved by the FDA?
OEC Elite MiniView received FDA 510(k) clearance on 2017-07-12, under approval number K171800.
What company makes OEC Elite MiniView?
OEC Elite MiniView is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for OEC Elite MiniView?
The FDA product code for OEC Elite MiniView 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.