S-Line
K号: K213191 · 2022-05-24
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决定日期2022-05-24
产品代码LGZ
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。
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器械摘要
S-Line is the device name listed in this FDA 510(k) record. The listed applicant is Barkey GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213191. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the S-Line?
S-Line is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Barkey GmbH & Co. KG. The 510(k) number is K213191.
When did S-Line receive FDA 510(k) clearance?
S-Line received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213191.
Who is the listed applicant for S-Line?
The FDA 510(k) record lists Barkey GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for S-Line?
The FDA product code for S-Line is LGZ.
相关器械（代码：LGZ）
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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