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FDA 510(k)

Neuro.Al Algorithm

K-Number: K200750 · 2020-11-06

ApplicantTerarecon,Inc.
Decision Date2020-11-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Neuro.Al Algorithm is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2020-11-06 under approval number K200750. 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 Neuro.Al Algorithm?

Neuro.Al Algorithm is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by Terarecon,Inc.. The 510(k) number is K200750.

When was Neuro.Al Algorithm approved by the FDA?

Neuro.Al Algorithm received FDA 510(k) clearance on 2020-11-06, under approval number K200750.

What company makes Neuro.Al Algorithm?

Neuro.Al Algorithm is manufactured by Terarecon,Inc..

What is the FDA product code for Neuro.Al Algorithm?

The FDA product code for Neuro.Al Algorithm is LLZ.

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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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