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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 the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2020-11-06 under 510(k) 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. The listed applicant is Terarecon,Inc.. The 510(k) number is K200750.

When did Neuro.Al Algorithm receive FDA 510(k) clearance?

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

Who is the listed applicant for Neuro.Al Algorithm?

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

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

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

Other records listing Terarecon,Inc. as applicant

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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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