UTC 3毫升药物药盒
K号: K230718 · 2023-06-15
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申请人Gilero, LLC
决定日期2023-06-15
产品代码MRZ
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
UTC 3mL Medication Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Gilero, LLC. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K230718. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UTC 3mL Medication Cartridge?
UTC 3mL Medication Cartridge is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Gilero, LLC. The 510(k) number is K230718.
When did UTC 3mL Medication Cartridge receive FDA 510(k) clearance?
UTC 3mL Medication Cartridge received FDA 510(k) clearance on 2023-06-15, under 510(k) number K230718.
Who is the listed applicant for UTC 3mL Medication Cartridge?
The FDA 510(k) record lists Gilero, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UTC 3mL Medication Cartridge?
The FDA product code for UTC 3mL Medication Cartridge is MRZ.
相关临床试验
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列明Gilero, 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：MRZ）
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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