MaxO2ME
K号: K153659 · 2016-06-10
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申请人Maxtec, LLC
决定日期2016-06-10
产品代码CCL
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
MaxO2ME is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K153659. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MaxO2ME?
MaxO2ME is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Maxtec, LLC. The 510(k) number is K153659.
When did MaxO2ME receive FDA 510(k) clearance?
MaxO2ME received FDA 510(k) clearance on 2016-06-10, under 510(k) number K153659.
Who is the listed applicant for MaxO2ME?
The FDA 510(k) record lists Maxtec, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MaxO2ME?
The FDA product code for MaxO2ME is CCL.
列明Maxtec, LLC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：CCL）
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。
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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