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FDA 510(k)

Tempo Smart Button

K-Number: K212217 · 2022-09-16

ApplicantEli Lilly and Company
Decision Date2022-09-16
Product CodeQOG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Tempo Smart Button is a medical device manufactured by Eli Lilly and Company. It received FDA 510(k) clearance on 2022-09-16 under approval number K212217. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tempo Smart Button?

Tempo Smart Button is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by Eli Lilly and Company. The 510(k) number is K212217.

When was Tempo Smart Button approved by the FDA?

Tempo Smart Button received FDA 510(k) clearance on 2022-09-16, under approval number K212217.

What company makes Tempo Smart Button?

Tempo Smart Button is manufactured by Eli Lilly and Company.

What is the FDA product code for Tempo Smart Button?

The FDA product code for Tempo Smart Button is QOG.

Other Devices by Eli Lilly and Company

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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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