无菌一次性使用注射器
K号: K210914 · 2021-12-17
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决定日期2021-12-17
产品代码FMF
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
Sterile Syringe for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Suyun Medical Material Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210914. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sterile Syringe for Single Use?
Sterile Syringe for Single Use is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Jiangsu Suyun Medical Material Co., Ltd.. The 510(k) number is K210914.
When did Sterile Syringe for Single Use receive FDA 510(k) clearance?
Sterile Syringe for Single Use received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210914.
Who is the listed applicant for Sterile Syringe for Single Use?
The FDA 510(k) record lists Jiangsu Suyun Medical Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile Syringe for Single Use?
The FDA product code for Sterile Syringe for Single Use is FMF.
相关临床试验
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：FMF）
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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