每秒都很重要-子宫球囊填塞（“ESM-UBT”）
K号: K191264 · 2019-10-30
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决定日期2019-10-30
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
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is the device name listed in this FDA 510(k) record. The listed applicant is Ujenzi Charitable Trust. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K191264. 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 Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Ujenzi Charitable Trust. The 510(k) number is K191264.
When did Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) receive FDA 510(k) clearance?
Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) received FDA 510(k) clearance on 2019-10-30, under 510(k) number K191264.
Who is the listed applicant for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?
The FDA 510(k) record lists Ujenzi Charitable Trust as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?
The FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) 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。
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 HealthK201199Jada 系统Alydia HealthK170622Bakri 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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