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FDA 510(k)

Mimics Cardiac Planner

K-Number: K233217 · 2024-02-12

Decision Date2024-02-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mimics Cardiac Planner is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2024-02-12 under approval number K233217. 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 Mimics Cardiac Planner?

Mimics Cardiac Planner is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Materialise NV. The 510(k) number is K233217.

When was Mimics Cardiac Planner approved by the FDA?

Mimics Cardiac Planner received FDA 510(k) clearance on 2024-02-12, under approval number K233217.

What company makes Mimics Cardiac Planner?

Mimics Cardiac Planner is manufactured by Materialise NV.

What is the FDA product code for Mimics Cardiac Planner?

The FDA product code for Mimics Cardiac Planner is LLZ.

Other Devices by Materialise NV

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Related Devices (Code: LLZ)

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.