FDA 510(k)

i-ED 线圈

K号: K192068 · 2020-04-25

决定日期2020-04-25

产品代码HCG

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

i-ED COIL is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Pharma America, LLC. It received FDA 510(k) clearance on 2020-04-25 under 510(k) number K192068. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-ED COIL?

i-ED COIL is a medical device that received FDA 510(k) clearance on 2020-04-25. The listed applicant is Kaneka Pharma America, LLC. The 510(k) number is K192068.

When did i-ED COIL receive FDA 510(k) clearance?

i-ED COIL received FDA 510(k) clearance on 2020-04-25, under 510(k) number K192068.

Who is the listed applicant for i-ED COIL?

The FDA 510(k) record lists Kaneka Pharma America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-ED COIL?

The FDA product code for i-ED COIL is HCG.

列明Kaneka Pharma America, LLC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。

K170247Lacriflow CL

相关器械（代码：HCG）

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。