一次性隔离服（S，M，L，XL，XXL，XXXL）
K号: K223304 · 2023-02-08
广告
决定日期2023-02-08
产品代码FYC
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Probtain Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K223304. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Xiamen Probtain Medical Technology Co., Ltd.. The 510(k) number is K223304.
When did Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-02-08, under 510(k) number K223304.
Who is the listed applicant for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?
The FDA 510(k) record lists Xiamen Probtain Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?
The FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is FYC.
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：FYC）
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。
K232849Halyard Tri-Layer AAMI 3隔离服，L，蓝色（54310），Halyard Tri-Layer AAMI 3隔离服，超大号，蓝色（54311）Owens & Minor (O&M) Halyard, Inc.K230135Copioumed 化疗隔离服Copioumed International, Inc.K223467一次性隔离服Nanning Tecbod Biological Technology Co., Ltd.K223411一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI等级3隔离服Paneffort, LLCK210414CoverU带胶纸一次性隔离服AAMI Level 4隔离服CoverU带胶纸一次性隔离服 - 化疗服Medtecs (Taiwan) Corp.
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。
广告