OxyMinder
K号: K213948 · 2022-03-17
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决定日期2022-03-17
产品代码CCL
咨询委员会AN
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器械摘要
OxyMinder is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 2022-03-17 under 510(k) number K213948. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OxyMinder?
OxyMinder is a medical device that received FDA 510(k) clearance on 2022-03-17. The listed applicant is Bio-Med Devices, Inc.. The 510(k) number is K213948.
When did OxyMinder receive FDA 510(k) clearance?
OxyMinder received FDA 510(k) clearance on 2022-03-17, under 510(k) number K213948.
Who is the listed applicant for OxyMinder?
The FDA 510(k) record lists Bio-Med Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OxyMinder?
The FDA product code for OxyMinder is CCL.
相关临床试验
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列明Bio-Med Devices, 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：CCL）
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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