DreamStation 2 系统，DreamStation 2 高级系统
K号: K200480 · 2020-07-10
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决定日期2020-07-10
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
DreamStation 2 System, DreamStation 2 Advanced System is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K200480. 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 DreamStation 2 System, DreamStation 2 Advanced System?
DreamStation 2 System, DreamStation 2 Advanced System is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Respironics, Inc.. The 510(k) number is K200480.
When did DreamStation 2 System, DreamStation 2 Advanced System receive FDA 510(k) clearance?
DreamStation 2 System, DreamStation 2 Advanced System received FDA 510(k) clearance on 2020-07-10, under 510(k) number K200480.
Who is the listed applicant for DreamStation 2 System, DreamStation 2 Advanced System?
FDA 510(k)记录中列出Respironics, Inc.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 DreamStation 2 System, DreamStation 2 Advanced System?
The FDA product code for DreamStation 2 System, DreamStation 2 Advanced System 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Respironics, Inc.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。
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