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FDA 510(k)

My Dose Coach

K-Number: K163099 · 2017-03-22

ApplicantSanofi, Inc.
Decision Date2017-03-22
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

My Dose Coach is a medical device manufactured by Sanofi, Inc.. It received FDA 510(k) clearance on 2017-03-22 under approval 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. It is manufactured by Sanofi, Inc.. The 510(k) number is K163099.

When was My Dose Coach approved by the FDA?

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

What company makes My Dose Coach?

My Dose Coach is manufactured by Sanofi, Inc..

What is the FDA product code for My Dose Coach?

The FDA product code for My Dose Coach is NDC.

Related Devices (Code: NDC)

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Official Source

View on FDA Database →

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

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