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FDA 510(k)

Merge Cardio

K-Number: K192276 · 2019-09-20

ApplicantMerge Healthcare Incorporated
Decision Date2019-09-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Merge Cardio is a medical device manufactured by Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2019-09-20 under approval number K192276. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merge Cardio?

Merge Cardio is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Merge Healthcare Incorporated. The 510(k) number is K192276.

When was Merge Cardio approved by the FDA?

Merge Cardio received FDA 510(k) clearance on 2019-09-20, under approval number K192276.

What company makes Merge Cardio?

Merge Cardio is manufactured by Merge Healthcare Incorporated.

What is the FDA product code for Merge Cardio?

The FDA product code for Merge Cardio is LLZ.

Other Devices by Merge Healthcare Incorporated

K152864Merge Hemo K173475Merge PACS K182290IBM iConnect Access K192455Merge PACS K203104IBM iConnect Access K233326Merge Hemo, Model RCSV2

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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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