电子龋齿检测器
K号: K170822 · 2017-09-11
广告
决定日期2017-09-11
产品代码NBL
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
Electronic Caries Detector is the device name listed in this FDA 510(k) record. The listed applicant is Ortek Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K170822. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Electronic Caries Detector?
Electronic Caries Detector is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Ortek Therapeutics, Inc.. The 510(k) number is K170822.
When did Electronic Caries Detector receive FDA 510(k) clearance?
Electronic Caries Detector received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170822.
Who is the listed applicant for Electronic Caries Detector?
The FDA 510(k) record lists Ortek Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electronic Caries Detector?
The FDA product code for Electronic Caries Detector is NBL.
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：NBL）
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