FDA 510(k)

胰岛素注射器

K号: K233794 · 2024-03-06

决定日期2024-03-06

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

Insulin Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Spm Medicare Pvt. , Ltd.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K233794. 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 Insulin Syringe?

Insulin Syringe is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Spm Medicare Pvt. , Ltd.. The 510(k) number is K233794.

When did Insulin Syringe receive FDA 510(k) clearance?

Insulin Syringe received FDA 510(k) clearance on 2024-03-06, under 510(k) number K233794.

Who is the listed applicant for Insulin Syringe?

The FDA 510(k) record lists Spm Medicare Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulin Syringe?

The FDA product code for Insulin Syringe is FMF.

列明Spm Medicare Pvt. , Ltd.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。

K231724冲洗注射器（预充0.9%氯化钠溶液）

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, LLC K252184SOL-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, LLC K253110Sol-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

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