MN-111
K号: K172825 · 2018-05-30
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决定日期2018-05-30
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
MN-111 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 2018-05-30 under 510(k) number K172825. 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 MN-111?
MN-111 is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is W&H Sterilization S.R.L.. The 510(k) number is K172825.
When did MN-111 receive FDA 510(k) clearance?
MN-111 received FDA 510(k) clearance on 2018-05-30, under 510(k) number K172825.
Who is the listed applicant for MN-111?
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 MN-111?
The FDA product code for MN-111 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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