Apogee
K号: K200401 · 2020-11-14
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决定日期2020-11-14
产品代码NFB
咨询委员会AN
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器械摘要
Apogee is the device name listed in this FDA 510(k) record. The listed applicant is Incoba Ltd D/B/A Dynaris. It received FDA 510(k) clearance on 2020-11-14 under 510(k) number K200401. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Apogee?
Apogee is a medical device that received FDA 510(k) clearance on 2020-11-14. The listed applicant is Incoba Ltd D/B/A Dynaris. The 510(k) number is K200401.
When did Apogee receive FDA 510(k) clearance?
Apogee received FDA 510(k) clearance on 2020-11-14, under 510(k) number K200401.
Who is the listed applicant for Apogee?
The FDA 510(k) record lists Incoba Ltd D/B/A Dynaris as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Apogee?
The FDA product code for Apogee is NFB.
相关临床试验
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相关器械（代码：NFB）
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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