PlaniMax 正畸软件
K号: K201036 · 2020-12-22
广告
决定日期2020-12-22
产品代码PNN
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
PlaniMax Orthodontic Software is the device name listed in this FDA 510(k) record. The listed applicant is Choice Biotech, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201036. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PlaniMax Orthodontic Software?
PlaniMax Orthodontic Software is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Choice Biotech, Inc.. The 510(k) number is K201036.
When did PlaniMax Orthodontic Software receive FDA 510(k) clearance?
PlaniMax Orthodontic Software received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201036.
Who is the listed applicant for PlaniMax Orthodontic Software?
The FDA 510(k) record lists Choice Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PlaniMax Orthodontic Software?
The FDA product code for PlaniMax Orthodontic Software is PNN.
相关临床试验
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：PNN）
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。
广告