PointCore外科口罩
K号: K220944 · 2022-09-09
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器械摘要
PointCore Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Pointcore, Inc.. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K220944. 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 PointCore Surgical Mask?
PointCore Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Pointcore, Inc.. The 510(k) number is K220944.
When did PointCore Surgical Mask receive FDA 510(k) clearance?
PointCore Surgical Mask received FDA 510(k) clearance on 2022-09-09, under 510(k) number K220944.
Who is the listed applicant for PointCore Surgical Mask?
The FDA 510(k) record lists Pointcore, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PointCore Surgical Mask?
The FDA product code for PointCore Surgical Mask 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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