WELLTRUST WT-III 平耳挂式口罩
K号: K211751 · 2021-09-17
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决定日期2021-09-17
产品代码FXX
咨询委员会SU
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决定实质等同
器械摘要
WELLTRUST WT-III Mask with Flat Earloop is the device name listed in this FDA 510(k) record. The listed applicant is Lonestar Meadows, LLC. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K211751. 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 WELLTRUST WT-III Mask with Flat Earloop?
WELLTRUST WT-III Mask with Flat Earloop is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Lonestar Meadows, LLC. The 510(k) number is K211751.
When did WELLTRUST WT-III Mask with Flat Earloop receive FDA 510(k) clearance?
WELLTRUST WT-III Mask with Flat Earloop received FDA 510(k) clearance on 2021-09-17, under 510(k) number K211751.
Who is the listed applicant for WELLTRUST WT-III Mask with Flat Earloop?
The FDA 510(k) record lists Lonestar Meadows, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WELLTRUST WT-III Mask with Flat Earloop?
The FDA product code for WELLTRUST WT-III Mask with Flat Earloop 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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