外科手术口罩，型号：EFMDS-L50Pn BLU
K号: K230380 · 2023-08-03
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器械摘要
Surgical Face Masks, Model: EFMDS-L50Pn BLU is the device name listed in this FDA 510(k) record. The listed applicant is Iris USA. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K230380. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Surgical Face Masks, Model: EFMDS-L50Pn BLU?
Surgical Face Masks, Model: EFMDS-L50Pn BLU is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Iris USA. The 510(k) number is K230380.
When did Surgical Face Masks, Model: EFMDS-L50Pn BLU receive FDA 510(k) clearance?
Surgical Face Masks, Model: EFMDS-L50Pn BLU received FDA 510(k) clearance on 2023-08-03, under 510(k) number K230380.
Who is the listed applicant for Surgical Face Masks, Model: EFMDS-L50Pn BLU?
The FDA 510(k) record lists Iris USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Surgical Face Masks, Model: EFMDS-L50Pn BLU?
The FDA product code for Surgical Face Masks, Model: EFMDS-L50Pn BLU is FXX.
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：FXX）
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。
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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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