OCT-Camera ID 21101A3
K号: K200516 · 2020-09-02
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决定日期2020-09-02
产品代码OBO
咨询委员会OP
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决定实质等同
器械摘要
OCT-Camera ID 21101A3 is the device name listed in this FDA 510(k) record. The listed applicant is Optomedical Technologies GmbH. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200516. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OCT-Camera ID 21101A3?
OCT-Camera ID 21101A3 is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Optomedical Technologies GmbH. The 510(k) number is K200516.
When did OCT-Camera ID 21101A3 receive FDA 510(k) clearance?
OCT-Camera ID 21101A3 received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200516.
Who is the listed applicant for OCT-Camera ID 21101A3?
The FDA 510(k) record lists Optomedical Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OCT-Camera ID 21101A3?
The FDA product code for OCT-Camera ID 21101A3 is OBO.
相关临床试验
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相关器械（代码：OBO）
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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