Huxley SANSA 家庭睡眠呼吸暂停测试仪 (1000-00)
K号: K240285 · 2024-07-15
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决定日期2024-07-15
产品代码MNR
咨询委员会AN
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器械摘要
Huxley SANSA Home Sleep Apnea Test (1000-00) is the device name listed in this FDA 510(k) record. The listed applicant is Huxley Medical. It received FDA 510(k) clearance on 2024-07-15 under 510(k) number K240285. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Huxley SANSA Home Sleep Apnea Test (1000-00)?
Huxley SANSA Home Sleep Apnea Test (1000-00) is a medical device that received FDA 510(k) clearance on 2024-07-15. The listed applicant is Huxley Medical. The 510(k) number is K240285.
When did Huxley SANSA Home Sleep Apnea Test (1000-00) receive FDA 510(k) clearance?
Huxley SANSA Home Sleep Apnea Test (1000-00) received FDA 510(k) clearance on 2024-07-15, under 510(k) number K240285.
Who is the listed applicant for Huxley SANSA Home Sleep Apnea Test (1000-00)?
The FDA 510(k) record lists Huxley Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Huxley SANSA Home Sleep Apnea Test (1000-00)?
The FDA product code for Huxley SANSA Home Sleep Apnea Test (1000-00) is MNR.
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列明Huxley Medical为申报人的其他记录
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相关器械（代码：MNR）
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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