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FDA 510(k)

Pre-Sure

K-Number: K230044 · 2023-05-26

ApplicantLazarus 3D
Decision Date2023-05-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pre-Sure is a medical device manufactured by Lazarus 3D. It received FDA 510(k) clearance on 2023-05-26 under approval number K230044. 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 Pre-Sure?

Pre-Sure is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Lazarus 3D. The 510(k) number is K230044.

When was Pre-Sure approved by the FDA?

Pre-Sure received FDA 510(k) clearance on 2023-05-26, under approval number K230044.

What company makes Pre-Sure?

Pre-Sure is manufactured by Lazarus 3D.

What is the FDA product code for Pre-Sure?

The FDA product code for Pre-Sure is 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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