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FDA 510(k)

TeraRecon Neuro

K-Number: K220349 · 2022-08-12

ApplicantTerarecon,Inc.
Decision Date2022-08-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TeraRecon Neuro is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220349. 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 TeraRecon Neuro?

TeraRecon Neuro is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Terarecon,Inc.. The 510(k) number is K220349.

When did TeraRecon Neuro receive FDA 510(k) clearance?

TeraRecon Neuro received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220349.

Who is the listed applicant for TeraRecon Neuro?

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 TeraRecon Neuro?

The FDA product code for TeraRecon Neuro is LLZ.

Other records listing Terarecon,Inc. as applicant

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Related Devices (Code: 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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