Inbrace正畸系统
K号: K203442 · 2021-02-19
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决定日期2021-02-19
产品代码PNN
咨询委员会DE
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决定实质等同
器械摘要
Inbrace Orthodontic System is the device name listed in this FDA 510(k) record. The listed applicant is Swift Health Systems, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K203442. 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 Inbrace Orthodontic System?
Inbrace Orthodontic System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Swift Health Systems, Inc.. The 510(k) number is K203442.
When did Inbrace Orthodontic System receive FDA 510(k) clearance?
Inbrace Orthodontic System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K203442.
Who is the listed applicant for Inbrace Orthodontic System?
The FDA 510(k) record lists Swift Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Inbrace Orthodontic System?
The FDA product code for Inbrace Orthodontic System 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。
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