OEC Elite MiniView
K-Number: K160131 · 2016-06-21
ApplicantGe Hangwei Medical Systems Co., Ltd.
Decision Date2016-06-21
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OEC Elite MiniView is a medical device manufactured by Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-06-21 under approval number K160131. 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 2016-06-21. It is manufactured by Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K160131.
When was OEC Elite MiniView approved by the FDA?
OEC Elite MiniView received FDA 510(k) clearance on 2016-06-21, under approval number K160131.
What company makes OEC Elite MiniView?
OEC Elite MiniView is manufactured by Ge Hangwei 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.