可调节反向拉力口罩
K号: K162543 · 2017-08-28
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决定日期2017-08-28
产品代码DZB
咨询委员会DE
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决定实质等同
器械摘要
Reverse Pull Adjustable Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Sawbros Industries Pvt., Ltd.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K162543. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Reverse Pull Adjustable Facemask?
Reverse Pull Adjustable Facemask is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Sawbros Industries Pvt., Ltd.. The 510(k) number is K162543.
When did Reverse Pull Adjustable Facemask receive FDA 510(k) clearance?
Reverse Pull Adjustable Facemask received FDA 510(k) clearance on 2017-08-28, under 510(k) number K162543.
Who is the listed applicant for Reverse Pull Adjustable Facemask?
The FDA 510(k) record lists Sawbros Industries Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reverse Pull Adjustable Facemask?
The FDA product code for Reverse Pull Adjustable Facemask is DZB.
相关临床试验
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相关器械（代码：DZB）
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。
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