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FDA 510(k)

JADE

K-Number: K202231 · 2020-12-10

ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
Decision Date2020-12-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JADE is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2020-12-10 under 510(k) 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. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K202231.

When did JADE receive FDA 510(k) clearance?

JADE received FDA 510(k) clearance on 2020-12-10, under 510(k) number K202231.

Who is the listed applicant for JADE?

The FDA 510(k) record lists OrbusNeich Medical (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JADE?

The FDA product code for JADE is LIT.

Other records listing OrbusNeich Medical (Shenzhen) Co., Ltd. as applicant

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Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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