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FDA 510(k)

TeraRecon Neuro

K-Number: K220349 · 2022-08-12

Decision Date2022-08-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TeraRecon Neuro is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2022-08-12 under approval 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. It is manufactured by Terarecon,Inc.. The 510(k) number is K220349.

When was TeraRecon Neuro approved by the FDA?

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

What company makes TeraRecon Neuro?

TeraRecon Neuro is manufactured by Terarecon,Inc..

What is the FDA product code for TeraRecon Neuro?

The FDA product code for TeraRecon Neuro is LLZ.

Other Devices by Terarecon,Inc.

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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.