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FDA 510(k)

PRE-SURE

K-Number: K201835 · 2021-07-08

ApplicantLazarus 3D, Inc.
Decision Date2021-07-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRE-SURE is a medical device manufactured by Lazarus 3D, Inc.. It received FDA 510(k) clearance on 2021-07-08 under approval number K201835. 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 2021-07-08. It is manufactured by Lazarus 3D, Inc.. The 510(k) number is K201835.

When was PRE-SURE approved by the FDA?

PRE-SURE received FDA 510(k) clearance on 2021-07-08, under approval number K201835.

What company makes PRE-SURE?

PRE-SURE is manufactured by Lazarus 3D, Inc..

What is the FDA product code for PRE-SURE?

The FDA product code for PRE-SURE is LLZ.

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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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