PolyWear® 个人防护三级隔离服
K号: K230384 · 2023-08-11
广告
决定日期2023-08-11
产品代码QPC
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
PolyWear® Personal Protective Level 3 Gown is the device name listed in this FDA 510(k) record. The listed applicant is PolyConversions, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K230384. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PolyWear® Personal Protective Level 3 Gown?
PolyWear® Personal Protective Level 3 Gown is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is PolyConversions, Inc.. The 510(k) number is K230384.
When did PolyWear® Personal Protective Level 3 Gown receive FDA 510(k) clearance?
PolyWear® Personal Protective Level 3 Gown received FDA 510(k) clearance on 2023-08-11, under 510(k) number K230384.
Who is the listed applicant for PolyWear® Personal Protective Level 3 Gown?
FDA 510(k)记录中列出PolyConversions, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for PolyWear® Personal Protective Level 3 Gown?
The FDA product code for PolyWear® Personal Protective Level 3 Gown is QPC.
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。
列明PolyConversions, Inc.为申报人的其他记录
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：QPC）
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。
广告