FDA 510(k)

Go Dose System

K-Number: K160949 · 2016-12-22

Decision Date2016-12-22

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Eli Lilly and Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.