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FDA 510(k)

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

K-Number: K233133 · 2024-04-01

ApplicantTalis Clinical, LLC
Decision Date2024-04-01
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Talis EMR with Talis +ACG (Talis EMR with +ACG) is the device name listed in this FDA 510(k) record. The listed applicant is Talis Clinical, LLC. It received FDA 510(k) clearance on 2024-04-01 under 510(k) 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. The listed applicant is Talis Clinical, LLC. The 510(k) number is K233133.

When did Talis EMR with Talis +ACG (Talis EMR with +ACG) receive FDA 510(k) clearance?

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

Who is the listed applicant for Talis EMR with Talis +ACG (Talis EMR with +ACG)?

The FDA 510(k) record lists Talis Clinical, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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