FDA 510(k)

AIBOLIT 3D+

K-Number: K222458 · 2023-01-12

Decision Date2023-01-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AIBOLIT 3D+ is the device name listed in this FDA 510(k) record. The listed applicant is Aibolit Technologies, LLC. It received FDA 510(k) clearance on 2023-01-12 under 510(k) 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. The listed applicant is Aibolit Technologies, LLC. The 510(k) number is K222458.

When did AIBOLIT 3D+ receive FDA 510(k) clearance?

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

Who is the listed applicant for AIBOLIT 3D+?

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

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

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

Other records listing Aibolit Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.