个性化治疗舒适设置（PTCS）
K号: K251657 · 2025-12-05
广告
申请人Resmed Corp
决定日期2025-12-05
产品代码BZD
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
Personalized Therapy Comfort Settings (PTCS) is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K251657. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Personalized Therapy Comfort Settings (PTCS)?
Personalized Therapy Comfort Settings (PTCS) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Resmed Corp. The 510(k) number is K251657.
When did Personalized Therapy Comfort Settings (PTCS) receive FDA 510(k) clearance?
Personalized Therapy Comfort Settings (PTCS) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251657.
Who is the listed applicant for Personalized Therapy Comfort Settings (PTCS)?
FDA 510(k)记录显示Resmed Corp为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Personalized Therapy Comfort Settings (PTCS)?
The FDA product code for Personalized Therapy Comfort Settings (PTCS) is BZD.
相关临床试验
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。
列明Resmed Corp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：BZD）
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。
广告