RXS 1000
K号: K202369 · 2021-09-15
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决定日期2021-09-15
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
RXS 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enterprise, Inc.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K202369. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RXS 1000?
RXS 1000 is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Rolence Enterprise, Inc.. The 510(k) number is K202369.
When did RXS 1000 receive FDA 510(k) clearance?
RXS 1000 received FDA 510(k) clearance on 2021-09-15, under 510(k) number K202369.
Who is the listed applicant for RXS 1000?
The FDA 510(k) record lists Rolence Enterprise, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RXS 1000?
The FDA product code for RXS 1000 is MUH.
列明Rolence Enterprise, Inc.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：MUH）
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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