Bluezone Model RX-450 空气净化器
K号: K212824 · 2022-02-17
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决定日期2022-02-17
产品代码FRA
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Bluezone Model RX-450 Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Bluezone Products, Inc.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K212824. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bluezone Model RX-450 Air Purifier?
Bluezone Model RX-450 Air Purifier is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Bluezone Products, Inc.. The 510(k) number is K212824.
When did Bluezone Model RX-450 Air Purifier receive FDA 510(k) clearance?
Bluezone Model RX-450 Air Purifier received FDA 510(k) clearance on 2022-02-17, under 510(k) number K212824.
Who is the listed applicant for Bluezone Model RX-450 Air Purifier?
The FDA 510(k) record lists Bluezone Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bluezone Model RX-450 Air Purifier?
The FDA product code for Bluezone Model RX-450 Air Purifier is FRA.
相关临床试验
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相关器械（代码：FRA）
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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