FDA 510(k)

Cardiovascular Suite 4.2.1

K-Number: K202094 · 2022-01-11

Decision Date2022-01-11

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Cardiovascular Suite 4.2.1 is a medical device manufactured by Quipu S.R.L. It received FDA 510(k) clearance on 2022-01-11 under approval number K202094. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardiovascular Suite 4.2.1?

Cardiovascular Suite 4.2.1 is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Quipu S.R.L. The 510(k) number is K202094.

When was Cardiovascular Suite 4.2.1 approved by the FDA?

Cardiovascular Suite 4.2.1 received FDA 510(k) clearance on 2022-01-11, under approval number K202094.

What company makes Cardiovascular Suite 4.2.1?

Cardiovascular Suite 4.2.1 is manufactured by Quipu S.R.L.

What is the FDA product code for Cardiovascular Suite 4.2.1?

The FDA product code for Cardiovascular Suite 4.2.1 is DQK.

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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.