Rejoni 宫内导管
K号: K222798 · 2022-12-16
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申请人Rejoni, Inc.
决定日期2022-12-16
产品代码LKF
咨询委员会OB
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决定实质等同
器械摘要
Rejoni Intrauterine Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Rejoni, Inc.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222798. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rejoni Intrauterine Catheter?
Rejoni Intrauterine Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Rejoni, Inc.. The 510(k) number is K222798.
When did Rejoni Intrauterine Catheter receive FDA 510(k) clearance?
Rejoni Intrauterine Catheter received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222798.
Who is the listed applicant for Rejoni Intrauterine Catheter?
The FDA 510(k) record lists Rejoni, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rejoni Intrauterine Catheter?
The FDA product code for Rejoni Intrauterine Catheter is LKF.
相关临床试验
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相关器械（代码：LKF）
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
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