Respire Pink AT (硬质，硬质/软质，EF)
K号: K192127 · 2020-02-05
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决定日期2020-02-05
产品代码LRK
咨询委员会DE
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决定实质等同
器械摘要
Respire Pink AT (Hard, Hard/Soft, EF) is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holdings. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192127. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Respire Pink AT (Hard, Hard/Soft, EF)?
Respire Pink AT (Hard, Hard/Soft, EF) is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Respire Medical Holdings. The 510(k) number is K192127.
When did Respire Pink AT (Hard, Hard/Soft, EF) receive FDA 510(k) clearance?
Respire Pink AT (Hard, Hard/Soft, EF) received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192127.
Who is the listed applicant for Respire Pink AT (Hard, Hard/Soft, EF)?
The FDA 510(k) record lists Respire Medical Holdings as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Respire Pink AT (Hard, Hard/Soft, EF)?
The FDA product code for Respire Pink AT (Hard, Hard/Soft, EF) is LRK.
相关临床试验
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相关器械（代码：LRK）
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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