Jada 系统 (Jada-2002)
K号: K253642 · 2026-05-15
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申请人Organon, LLC
决定日期2026-05-15
产品代码OQY
咨询委员会OB
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决定实质等同
器械摘要
Jada System (Jada-2002) is the device name listed in this FDA 510(k) record. The listed applicant is Organon, LLC. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K253642. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Jada System (Jada-2002)?
Jada System (Jada-2002) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Organon, LLC. The 510(k) number is K253642.
When did Jada System (Jada-2002) receive FDA 510(k) clearance?
Jada System (Jada-2002) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253642.
Who is the listed applicant for Jada System (Jada-2002)?
The FDA 510(k) record lists Organon, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Jada System (Jada-2002)?
The FDA product code for Jada System (Jada-2002) is OQY.
相关临床试验
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相关器械（代码：OQY）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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