Shina 注射器; Shina 安全注射器
K号: K231165 · 2023-10-27
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决定日期2023-10-27
产品代码MEG
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
Shina Syringe; Shina Safety Syringe 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 2023-10-27 under 510(k) number K231165. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Shina Syringe; Shina Safety Syringe?
Shina Syringe; Shina Safety Syringe is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Shina Med Corporation. The 510(k) number is K231165.
When did Shina Syringe; Shina Safety Syringe receive FDA 510(k) clearance?
Shina Syringe; Shina Safety Syringe received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231165.
Who is the listed applicant for Shina Syringe; Shina Safety Syringe?
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 Shina Syringe; Shina Safety Syringe?
The FDA product code for Shina Syringe; Shina Safety Syringe is MEG.
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。
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：MEG）
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。
K252098PA3X可拆卸安全套筒注射器（带针）（SC-23ED / SD-23ED）Methyl Co., Ltd.K250847蒸汽盾Vault Paragon Group, Inc.K230287SaviSafe 安全设备Suzhou Savicred Biotechnology Co., Ltd.K231907Medline 安全胰岛素和TB注射器Medline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLCK220114PowerPAK 注射器Vault Paragon Group, Inc.
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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