Orthodontic Facemask
K号: K202855 · 2021-06-21
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决定日期2021-06-21
产品代码DZB
咨询委员会DE
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器械摘要
Orthodontic Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Ita.O Italian Orthodontic System S.R.L.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K202855. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Orthodontic Facemask?
Orthodontic Facemask is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Ita.O Italian Orthodontic System S.R.L.. The 510(k) number is K202855.
When did Orthodontic Facemask receive FDA 510(k) clearance?
Orthodontic Facemask received FDA 510(k) clearance on 2021-06-21, under 510(k) number K202855.
Who is the listed applicant for Orthodontic Facemask?
The FDA 510(k) record lists Ita.O Italian Orthodontic System S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthodontic Facemask?
The FDA product code for Orthodontic Facemask is DZB.
相关临床试验
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相关器械（代码：DZB）
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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