F&P Optiflow 氧气套件 (AA451J)
K号: K233821 · 2024-06-13
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决定日期2024-06-13
产品代码BTT
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
F&P Optiflow Oxygen Kit (AA451J) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K233821. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the F&P Optiflow Oxygen Kit (AA451J)?
F&P Optiflow Oxygen Kit (AA451J) is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K233821.
When did F&P Optiflow Oxygen Kit (AA451J) receive FDA 510(k) clearance?
F&P Optiflow Oxygen Kit (AA451J) received FDA 510(k) clearance on 2024-06-13, under 510(k) number K233821.
Who is the listed applicant for F&P Optiflow Oxygen Kit (AA451J)?
The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for F&P Optiflow Oxygen Kit (AA451J)?
The FDA product code for F&P Optiflow Oxygen Kit (AA451J) is BTT.
相关临床试验
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列明Fisher & Paykel Healthcare, 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。
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相关器械（代码：BTT）
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。
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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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