IDx-DR
K号: K203629 · 2021-06-10
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决定日期2021-06-10
产品代码PIB
咨询委员会OP
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决定实质等同
器械摘要
IDx-DR is the device name listed in this FDA 510(k) record. The listed applicant is Digital Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K203629. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IDx-DR?
IDx-DR is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Digital Diagnostics, Inc.. The 510(k) number is K203629.
When did IDx-DR receive FDA 510(k) clearance?
IDx-DR received FDA 510(k) clearance on 2021-06-10, under 510(k) number K203629.
Who is the listed applicant for IDx-DR?
The FDA 510(k) record lists Digital Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IDx-DR?
The FDA product code for IDx-DR is PIB.
列明Digital Diagnostics, 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：PIB）
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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