FDA 510(k)

EndoRotor

K号: K170120 · 2017-04-18

决定日期2017-04-18

产品代码PTE

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

EndoRotor is the device name listed in this FDA 510(k) record. The listed applicant is Interscope, Inc.. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K170120. The device is classified under product code PTE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EndoRotor?

EndoRotor is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Interscope, Inc.. The 510(k) number is K170120.

When did EndoRotor receive FDA 510(k) clearance?

EndoRotor received FDA 510(k) clearance on 2017-04-18, under 510(k) number K170120.

Who is the listed applicant for EndoRotor?

The FDA 510(k) record lists Interscope, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoRotor?

The FDA product code for EndoRotor is PTE.

列明Interscope, Inc.为申报人的其他记录

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。

K190715EndoRotor 控制台, EndoRotor 导管, EndoRotor 样本陷阱, EndoRotor 过滤器套装, EndoRotor 滚筒支架 K181127EndoRotor 控制台, EndoRotor 导管, EndoRotor 样本陷阱, EndoRotor 过滤器套装, EndoRotor 脚踏控制器

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。