Sure-Fine胰岛素注射器
K号: K210848 · 2022-03-01
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决定日期2022-03-01
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
Sure-Fine Insulin Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K210848. 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 Sure-Fine Insulin Syringes?
Sure-Fine Insulin Syringes is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Shina Med Corporation. The 510(k) number is K210848.
When did Sure-Fine Insulin Syringes receive FDA 510(k) clearance?
Sure-Fine Insulin Syringes received FDA 510(k) clearance on 2022-03-01, under 510(k) number K210848.
Who is the listed applicant for Sure-Fine Insulin Syringes?
The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sure-Fine Insulin Syringes?
The FDA product code for Sure-Fine Insulin Syringes is FMF.
相关临床试验
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列明Shina Med Corporation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：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。
K262581GraftGun® 全能移植物输送系统（GDS®）SurGenTec, LLCK252184SOL-M可更换针盘式卢埃尔锁注射器Sol-Millennium Medical, Inc.K253747一次性笔式注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ 安全胰岛素注射器embecta Medical II, LLCK253110Sol-Glide安全针；带注射器的Sol-Glide安全针。Sol-Millennium Medical, Inc.K260514Profoject™ 安全针；Profoject™ 带安全针的注射器；Profoject™ 低死腔注射器带安全针CMT Health PTE., Ltd.
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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