FDA 510(k)

CHIRANA胰岛素注射器

K号: K201044 · 2022-01-18

决定日期2022-01-18

产品代码FMF

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决定实质等同

器械摘要

CHIRANA Insulin Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K201044. 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 CHIRANA Insulin Syringes?

CHIRANA Insulin Syringes is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Chirana T. Injecta. The 510(k) number is K201044.

When did CHIRANA Insulin Syringes receive FDA 510(k) clearance?

CHIRANA Insulin Syringes received FDA 510(k) clearance on 2022-01-18, under 510(k) number K201044.

Who is the listed applicant for CHIRANA Insulin Syringes?

The FDA 510(k) record lists Chirana T. Injecta as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIRANA Insulin Syringes?

The FDA product code for CHIRANA Insulin Syringes is FMF.

列明Chirana T. Injecta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。

K242434胰岛素注射器 K220614MEDOJECT 细针 K201009CHIRAVAC 血液采集针

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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