FDA 510(k)

ThinkQA

K-Number: K180106 · 2018-03-13

Decision Date2018-03-13

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ThinkQA is a medical device manufactured by Dosisoft. It received FDA 510(k) clearance on 2018-03-13 under approval number K180106. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThinkQA?

ThinkQA is a medical device that received FDA 510(k) clearance on 2018-03-13. It is manufactured by Dosisoft. The 510(k) number is K180106.

When was ThinkQA approved by the FDA?

ThinkQA received FDA 510(k) clearance on 2018-03-13, under approval number K180106.

What company makes ThinkQA?

ThinkQA is manufactured by Dosisoft.

What is the FDA product code for ThinkQA?

The FDA product code for ThinkQA is IYE.

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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.