FDA 510(k)

PRE-SURE

K-Number: K201835 · 2021-07-08

Decision Date2021-07-08

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PRE-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Lazarus 3D, Inc.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) 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. The listed applicant is Lazarus 3D, Inc.. The 510(k) number is K201835.

When did PRE-SURE receive FDA 510(k) clearance?

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

Who is the listed applicant for PRE-SURE?

The FDA 510(k) record lists Lazarus 3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-SURE?

The FDA product code for PRE-SURE is LLZ.

Other records listing Lazarus 3D, Inc. 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.

K230044Pre-Sure

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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.