DeviceClearance

Pre-Sure— 510(k) K230044

Substantially Equivalent

Lazarus 3D

FDA 510(k) clearance K230044 for Pre-Sure, Substantially Equivalent on 2023-05-26. Applicant: Lazarus 3D. Device class: 2.

Clearance details

Applicant
Lazarus 3D
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Albany, OR, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LLZ

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.