Lexa MINI (RIS-303, RIS-305)
K号: K223858 · 2023-05-05
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决定日期2023-05-05
产品代码FLE
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Lexa MINI (RIS-303, RIS-305) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Sterilization S.R.L.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K223858. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lexa MINI (RIS-303, RIS-305)?
Lexa MINI (RIS-303, RIS-305) is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is W&H Sterilization S.R.L.. The 510(k) number is K223858.
When did Lexa MINI (RIS-303, RIS-305) receive FDA 510(k) clearance?
Lexa MINI (RIS-303, RIS-305) received FDA 510(k) clearance on 2023-05-05, under 510(k) number K223858.
Who is the listed applicant for Lexa MINI (RIS-303, RIS-305)?
The FDA 510(k) record lists W&H Sterilization S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lexa MINI (RIS-303, RIS-305)?
The FDA product code for Lexa MINI (RIS-303, RIS-305) is FLE.
列明W&H Sterilization S.R.L.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：FLE）
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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