带DentiTrac的Respire Pink系列
K号: K170692 · 2017-05-26
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决定日期2017-05-26
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 Series with DentiTrac is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holding. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170692. 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 Series with DentiTrac?
Respire Pink Series with DentiTrac is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Respire Medical Holding. The 510(k) number is K170692.
When did Respire Pink Series with DentiTrac receive FDA 510(k) clearance?
Respire Pink Series with DentiTrac received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170692.
Who is the listed applicant for Respire Pink Series with DentiTrac?
The FDA 510(k) record lists Respire Medical Holding as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Respire Pink Series with DentiTrac?
The FDA product code for Respire Pink Series with DentiTrac 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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