O2VENT T
K号: K161832 · 2016-09-23
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决定日期2016-09-23
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
O2VENT T is the device name listed in this FDA 510(k) record. The listed applicant is Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K161832. 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 O2VENT T?
O2VENT T is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is Oventus Manufacturing Pty, Ltd.. The 510(k) number is K161832.
When did O2VENT T receive FDA 510(k) clearance?
O2VENT T received FDA 510(k) clearance on 2016-09-23, under 510(k) number K161832.
Who is the listed applicant for O2VENT T?
The FDA 510(k) record lists Oventus Manufacturing Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for O2VENT T?
The FDA product code for O2VENT T is LRK.
列明Oventus Manufacturing Pty, Ltd.为申报人的其他记录
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：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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