Solas OR
K号: K213691 · 2021-12-22
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器械摘要
Solas OR is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging, Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213691. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Solas OR?
Solas OR is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Cirdan Imaging, Ltd.. The 510(k) number is K213691.
When did Solas OR receive FDA 510(k) clearance?
Solas OR received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213691.
Who is the listed applicant for Solas OR?
The FDA 510(k) record lists Cirdan Imaging, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solas OR?
The FDA product code for Solas OR is MWP.
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:MWP)
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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