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FDA 510(k)

AIBOLIT 3D+

K-Number: K222458 · 2023-01-12

ApplicantAibolit Technologies, LLC
Decision Date2023-01-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIBOLIT 3D+ is a medical device manufactured by Aibolit Technologies, LLC. It received FDA 510(k) clearance on 2023-01-12 under approval number K222458. 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 AIBOLIT 3D+?

AIBOLIT 3D+ is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Aibolit Technologies, LLC. The 510(k) number is K222458.

When was AIBOLIT 3D+ approved by the FDA?

AIBOLIT 3D+ received FDA 510(k) clearance on 2023-01-12, under approval number K222458.

What company makes AIBOLIT 3D+?

AIBOLIT 3D+ is manufactured by Aibolit Technologies, LLC.

What is the FDA product code for AIBOLIT 3D+?

The FDA product code for AIBOLIT 3D+ is LLZ.

Other Devices by Aibolit Technologies, LLC

K211443AIBOLIT 3D+

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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.

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