O2Vent Optima
K号: K190236 · 2019-08-29
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决定日期2019-08-29
产品代码LRK
咨询委员会DE
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器械摘要
O2Vent Optima 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 2019-08-29 under 510(k) number K190236. 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 Optima?
O2Vent Optima is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Oventus Manufacturing Pty, Ltd.. The 510(k) number is K190236.
When did O2Vent Optima receive FDA 510(k) clearance?
O2Vent Optima received FDA 510(k) clearance on 2019-08-29, under 510(k) number K190236.
Who is the listed applicant for O2Vent Optima?
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 Optima?
The FDA product code for O2Vent Optima is LRK.
相关临床试验
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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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