JADE
K-Number: K202231 · 2020-12-10
Decision Date2020-12-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
JADE is a medical device manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2020-12-10 under approval number K202231. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JADE?
JADE is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K202231.
When was JADE approved by the FDA?
JADE received FDA 510(k) clearance on 2020-12-10, under approval number K202231.
What company makes JADE?
JADE is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd..
What is the FDA product code for JADE?
The FDA product code for JADE is LIT.
Other Devices by OrbusNeich Medical (Shenzhen) Co., Ltd.
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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.