坚固型制氧机 (ROG) (RO01-00001)
K号: K240561 · 2024-12-06
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决定日期2024-12-06
产品代码CAW
咨询委员会AN
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决定实质等同
器械摘要
Rugged Oxygen Generator (ROG) (RO01-00001) is the device name listed in this FDA 510(k) record. The listed applicant is Molecular Products , Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K240561. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rugged Oxygen Generator (ROG) (RO01-00001)?
Rugged Oxygen Generator (ROG) (RO01-00001) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Molecular Products , Ltd.. The 510(k) number is K240561.
When did Rugged Oxygen Generator (ROG) (RO01-00001) receive FDA 510(k) clearance?
Rugged Oxygen Generator (ROG) (RO01-00001) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K240561.
Who is the listed applicant for Rugged Oxygen Generator (ROG) (RO01-00001)?
The FDA 510(k) record lists Molecular Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rugged Oxygen Generator (ROG) (RO01-00001)?
The FDA product code for Rugged Oxygen Generator (ROG) (RO01-00001) is CAW.
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。
相关器械（代码：CAW）
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。
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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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