airVata™
K号: K240427 · 2024-02-14
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决定日期2024-02-14
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
airVata™ is the device name listed in this FDA 510(k) record. The listed applicant is Gelb Practice Solutions, Inc.. It received FDA 510(k) clearance on 2024-02-14 under 510(k) number K240427. 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 airVata™?
airVata™ is a medical device that received FDA 510(k) clearance on 2024-02-14. The listed applicant is Gelb Practice Solutions, Inc.. The 510(k) number is K240427.
When did airVata™ receive FDA 510(k) clearance?
airVata™ received FDA 510(k) clearance on 2024-02-14, under 510(k) number K240427.
Who is the listed applicant for airVata™?
The FDA 510(k) record lists Gelb Practice Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for airVata™?
The FDA product code for airVata™ 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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