PRE-SURE— 510(k) K201835

Substantially Equivalent

Lazarus 3D, Inc.

FDA 510(k) clearance K201835 for PRE-SURE, Substantially Equivalent on 2021-07-08. Applicant: Lazarus 3D, Inc..

Clearance details

Applicant: Lazarus 3D, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-07-02
Decision date: 2021-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Corvallis, OR, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.