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FDA 510(k)

Aline Ablation Intelligence

K-Number: K202297 · 2020-09-11

Decision Date2020-09-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aline Ablation Intelligence is a medical device manufactured by Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2020-09-11 under approval number K202297. 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 Aline Ablation Intelligence?

Aline Ablation Intelligence is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Mirada Medical, Ltd.. The 510(k) number is K202297.

When was Aline Ablation Intelligence approved by the FDA?

Aline Ablation Intelligence received FDA 510(k) clearance on 2020-09-11, under approval number K202297.

What company makes Aline Ablation Intelligence?

Aline Ablation Intelligence is manufactured by Mirada Medical, Ltd..

What is the FDA product code for Aline Ablation Intelligence?

The FDA product code for Aline Ablation Intelligence is LLZ.

Other Devices by Mirada Medical, Ltd.

Related Devices (Code: LLZ)

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.