丙烯酸赫斯特矫正器带微型录音器
K号: K170606 · 2017-11-16
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决定日期2017-11-16
产品代码PLC
咨询委员会DE
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决定实质等同
器械摘要
Acrylic Herbst Appliance with Micro-Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Gergen'S Orthodontic Lab. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K170606. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Acrylic Herbst Appliance with Micro-Recorder?
Acrylic Herbst Appliance with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Gergen'S Orthodontic Lab. The 510(k) number is K170606.
When did Acrylic Herbst Appliance with Micro-Recorder receive FDA 510(k) clearance?
Acrylic Herbst Appliance with Micro-Recorder received FDA 510(k) clearance on 2017-11-16, under 510(k) number K170606.
Who is the listed applicant for Acrylic Herbst Appliance with Micro-Recorder?
The FDA 510(k) record lists Gergen'S Orthodontic Lab as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Acrylic Herbst Appliance with Micro-Recorder?
The FDA product code for Acrylic Herbst Appliance with Micro-Recorder is PLC.
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：PLC）
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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