RADx 口腔内装置，用于打鼾和睡眠呼吸暂停
K号: K230532 · 2023-07-12
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决定日期2023-07-12
产品代码LQZ
咨询委员会DE
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器械摘要
RADx Intraoral Appliance for Snoring and Sleep Apnea is the device name listed in this FDA 510(k) record. The listed applicant is Achaemenid, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K230532. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RADx Intraoral Appliance for Snoring and Sleep Apnea?
RADx Intraoral Appliance for Snoring and Sleep Apnea is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is Achaemenid, LLC. The 510(k) number is K230532.
When did RADx Intraoral Appliance for Snoring and Sleep Apnea receive FDA 510(k) clearance?
RADx Intraoral Appliance for Snoring and Sleep Apnea received FDA 510(k) clearance on 2023-07-12, under 510(k) number K230532.
Who is the listed applicant for RADx Intraoral Appliance for Snoring and Sleep Apnea?
FDA 510(k)记录显示Achaemenid, LLC为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for RADx Intraoral Appliance for Snoring and Sleep Apnea?
The FDA product code for RADx Intraoral Appliance for Snoring and Sleep Apnea is LQZ.
相关临床试验
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列明Achaemenid, LLC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。
相关器械（代码：LQZ）
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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