Jada 系统
K号: K201199 · 2020-08-28
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决定日期2020-08-28
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 is the device name listed in this FDA 510(k) record. The listed applicant is Alydia Health. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K201199. 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 System is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Alydia Health. The 510(k) number is K201199.
When did Jada System receive FDA 510(k) clearance?
Jada System received FDA 510(k) clearance on 2020-08-28, under 510(k) number K201199.
Who is the listed applicant for Jada System?
The FDA 510(k) record lists Alydia Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Jada System?
The FDA product code for Jada System is OQY.
相关临床试验
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。
列明Alydia Health为申报人的其他记录
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。
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。
K253642Jada 系统 (Jada-2002)Organon, LLCK230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K223098Bakri Essential Postpartum BalloonCook IncorporatedK212757Jada 系统Alydia HealthK191264每秒都很重要-子宫球囊填塞（“ESM-UBT”）Ujenzi Charitable TrustK170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated
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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