FDA 510(k)

InPen系统

K号: K201337 · 2020-06-18

决定日期2020-06-18

产品代码NDC

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决定实质等同

器械摘要

InPen System is the device name listed in this FDA 510(k) record. The listed applicant is Companion Medical, Inc.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K201337. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InPen System?

InPen System is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Companion Medical, Inc.. The 510(k) number is K201337.

When did InPen System receive FDA 510(k) clearance?

InPen System received FDA 510(k) clearance on 2020-06-18, under 510(k) number K201337.

Who is the listed applicant for InPen System?

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

What is the FDA product code for InPen System?

The FDA product code for InPen System is NDC.

列明Companion Medical, 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。

K190487InPen剂量计算器 K192841InPen系统 K181327InPen剂量计算器 K160629InPen

官方来源

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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。