FDA 510(k)

My Dose Coach

K-Number: K163099 · 2017-03-22

Decision Date2017-03-22

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

My Dose Coach is the device name listed in this FDA 510(k) record. The listed applicant is Sanofi, Inc.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K163099. 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 My Dose Coach?

My Dose Coach is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Sanofi, Inc.. The 510(k) number is K163099.

When did My Dose Coach receive FDA 510(k) clearance?

My Dose Coach received FDA 510(k) clearance on 2017-03-22, under 510(k) number K163099.

Who is the listed applicant for My Dose Coach?

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

What is the FDA product code for My Dose Coach?

The FDA product code for My Dose Coach is NDC.

Other records listing Sanofi, Inc. 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.

K171230My Dose Coach

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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.