CONTEC Oxygen Concentrator
K号: K180837 · 2019-01-10
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决定日期2019-01-10
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
CONTEC Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K180837. 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 CONTEC Oxygen Concentrator?
CONTEC Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K180837.
When did CONTEC Oxygen Concentrator receive FDA 510(k) clearance?
CONTEC Oxygen Concentrator received FDA 510(k) clearance on 2019-01-10, under 510(k) number K180837.
Who is the listed applicant for CONTEC Oxygen Concentrator?
The FDA 510(k) record lists Contec Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CONTEC Oxygen Concentrator?
The FDA product code for CONTEC Oxygen Concentrator is CAW.
相关临床试验
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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
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