Artiglass NRFitTM Tip L.O.R. Glass Syringes
K号: K213800 · 2022-05-19
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决定日期2022-05-19
产品代码QEH
咨询委员会医疗设备监管文本翻译如下：
HO
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器械摘要
Artiglass NRFitTM Tip L.O.R. Glass Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Artiglass Srl. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K213800. The device is classified under product code QEH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Artiglass NRFitTM Tip L.O.R. Glass Syringes?
Artiglass NRFitTM Tip L.O.R. Glass Syringes is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Artiglass Srl. The 510(k) number is K213800.
When did Artiglass NRFitTM Tip L.O.R. Glass Syringes receive FDA 510(k) clearance?
Artiglass NRFitTM Tip L.O.R. Glass Syringes received FDA 510(k) clearance on 2022-05-19, under 510(k) number K213800.
Who is the listed applicant for Artiglass NRFitTM Tip L.O.R. Glass Syringes?
The FDA 510(k) record lists Artiglass Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Artiglass NRFitTM Tip L.O.R. Glass Syringes?
The FDA product code for Artiglass NRFitTM Tip L.O.R. Glass Syringes is QEH.
相关临床试验
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相关器械（代码：QEH）
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。
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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