Respond OC 节流调节器（130-0800）
K号: K250322 · 2025-07-24
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决定日期2025-07-24
产品代码NFB
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
Respond OC Conserving Regulator (130-0800) is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Respiratory. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K250322. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Respond OC Conserving Regulator (130-0800)?
Respond OC Conserving Regulator (130-0800) is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Responsive Respiratory. The 510(k) number is K250322.
When did Respond OC Conserving Regulator (130-0800) receive FDA 510(k) clearance?
Respond OC Conserving Regulator (130-0800) received FDA 510(k) clearance on 2025-07-24, under 510(k) number K250322.
Who is the listed applicant for Respond OC Conserving Regulator (130-0800)?
The FDA 510(k) record lists Responsive Respiratory as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Respond OC Conserving Regulator (130-0800)?
The FDA product code for Respond OC Conserving Regulator (130-0800) is NFB.
相关临床试验
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相关器械（代码：NFB）
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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