ClearEdge平衡系统
K号: K183661 · 2019-10-22
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器械摘要
ClearEdge Balance System is the device name listed in this FDA 510(k) record. The listed applicant is Quadrant Biosciences. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K183661. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.
常见问题
What is the ClearEdge Balance System?
ClearEdge Balance System is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Quadrant Biosciences. The 510(k) number is K183661.
When did ClearEdge Balance System receive FDA 510(k) clearance?
ClearEdge Balance System received FDA 510(k) clearance on 2019-10-22, under 510(k) number K183661.
Who is the listed applicant for ClearEdge Balance System?
The FDA 510(k) record lists Quadrant Biosciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClearEdge Balance System?
The FDA product code for ClearEdge Balance System is LXV.
相关临床试验
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相关器械（代码：LXV）
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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