Revitalair 430+
K号: K220290 · 2023-05-04
广告
决定日期2023-05-04
产品代码CBF
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Revitalair 430+ is the device name listed in this FDA 510(k) record. The listed applicant is Us Hyperbaric Network. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K220290. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Revitalair 430+?
Revitalair 430+ is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Us Hyperbaric Network. The 510(k) number is K220290.
When did Revitalair 430+ receive FDA 510(k) clearance?
Revitalair 430+ received FDA 510(k) clearance on 2023-05-04, under 510(k) number K220290.
Who is the listed applicant for Revitalair 430+?
The FDA 510(k) record lists Us Hyperbaric Network as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Revitalair 430+?
The FDA product code for Revitalair 430+ is CBF.
相关临床试验
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：CBF）
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。
广告