Edge Air(1417) 数字平板 X 射线探测器
K号: K201503 · 2020-06-29
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器械摘要
Edge Air(1417) Digital Flat Panel X-ray Detector is the device name listed in this FDA 510(k) record. The listed applicant is Osko, Inc.. It received FDA 510(k) clearance on 2020-06-29 under 510(k) number K201503. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Edge Air(1417) Digital Flat Panel X-ray Detector?
Edge Air(1417) Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Osko, Inc.. The 510(k) number is K201503.
When did Edge Air(1417) Digital Flat Panel X-ray Detector receive FDA 510(k) clearance?
Edge Air(1417) Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2020-06-29, under 510(k) number K201503.
Who is the listed applicant for Edge Air(1417) Digital Flat Panel X-ray Detector?
The FDA 510(k) record lists Osko, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Edge Air(1417) Digital Flat Panel X-ray Detector?
The FDA product code for Edge Air(1417) Digital Flat Panel X-ray Detector is MQB.
相关临床试验
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列明Osko, 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：MQB）
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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