ID-Cap系统
K号: K183052 · 2019-12-06
广告
决定日期2019-12-06
产品代码OZW
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
ID-Cap System is the device name listed in this FDA 510(k) record. The listed applicant is Etectrx, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K183052. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ID-Cap System?
ID-Cap System is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Etectrx, Inc.. The 510(k) number is K183052.
When did ID-Cap System receive FDA 510(k) clearance?
ID-Cap System received FDA 510(k) clearance on 2019-12-06, under 510(k) number K183052.
Who is the listed applicant for ID-Cap System?
The FDA 510(k) record lists Etectrx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ID-Cap System?
The FDA product code for ID-Cap System is OZW.
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：OZW）
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