IFM 手术口罩型号 SM3
K号: K202214 · 2021-03-02
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器械摘要
IFM Surgical Mask Model SM3 is the device name listed in this FDA 510(k) record. The listed applicant is Fssc, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K202214. 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 IFM Surgical Mask Model SM3?
IFM Surgical Mask Model SM3 is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Fssc, LLC. The 510(k) number is K202214.
When did IFM Surgical Mask Model SM3 receive FDA 510(k) clearance?
IFM Surgical Mask Model SM3 received FDA 510(k) clearance on 2021-03-02, under 510(k) number K202214.
Who is the listed applicant for IFM Surgical Mask Model SM3?
The FDA 510(k) record lists Fssc, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IFM Surgical Mask Model SM3?
The FDA product code for IFM Surgical Mask Model SM3 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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