FDA 510(k)

Go Dose System

K号: K160949 · 2016-12-22

决定日期2016-12-22

产品代码NDC

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决定实质等同

器械摘要

Go Dose System is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160949. 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 Go Dose System?

Go Dose System is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Eli Lilly and Company. The 510(k) number is K160949.

When did Go Dose System receive FDA 510(k) clearance?

Go Dose System received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160949.

Who is the listed applicant for Go Dose System?

The FDA 510(k) record lists Eli Lilly and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Go Dose System?

The FDA product code for Go Dose System is NDC.

列明Eli Lilly and Company为申报人的其他记录

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