SafeR 注射器和 SafeR 针
K号: K221981 · 2022-12-29
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决定日期2022-12-29
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
SafeR Syringe and SafeR Sting is the device name listed in this FDA 510(k) record. The listed applicant is Roncadelle Operations Srl. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221981. 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 SafeR Syringe and SafeR Sting?
SafeR Syringe and SafeR Sting is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Roncadelle Operations Srl. The 510(k) number is K221981.
When did SafeR Syringe and SafeR Sting receive FDA 510(k) clearance?
SafeR Syringe and SafeR Sting received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221981.
Who is the listed applicant for SafeR Syringe and SafeR Sting?
The FDA 510(k) record lists Roncadelle Operations Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SafeR Syringe and SafeR Sting?
The FDA product code for SafeR Syringe and SafeR Sting 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。
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.K231165Shina 注射器; Shina 安全注射器Shina Med CorporationK231907Medline 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, LLC
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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