FDA 510(k)

Talis EMR with Talis +ACG (Talis EMR with +ACG)

K-Number: K233133 · 2024-04-01

Decision Date2024-04-01

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Talis EMR with Talis +ACG (Talis EMR with +ACG) is a medical device manufactured by Talis Clinical, LLC. It received FDA 510(k) clearance on 2024-04-01 under approval number K233133. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Talis EMR with Talis +ACG (Talis EMR with +ACG)?

Talis EMR with Talis +ACG (Talis EMR with +ACG) is a medical device that received FDA 510(k) clearance on 2024-04-01. It is manufactured by Talis Clinical, LLC. The 510(k) number is K233133.

When was Talis EMR with Talis +ACG (Talis EMR with +ACG) approved by the FDA?

Talis EMR with Talis +ACG (Talis EMR with +ACG) received FDA 510(k) clearance on 2024-04-01, under approval number K233133.

What company makes Talis EMR with Talis +ACG (Talis EMR with +ACG)?

Talis EMR with Talis +ACG (Talis EMR with +ACG) is manufactured by Talis Clinical, LLC.

What is the FDA product code for Talis EMR with Talis +ACG (Talis EMR with +ACG)?

The FDA product code for Talis EMR with Talis +ACG (Talis EMR with +ACG) is MWI.

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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.