BIOJET— 510(k) K122329

Substantially Equivalent

Jet Soft Srl

FDA 510(k) clearance K122329 for BIOJET, Substantially Equivalent on 2012-08-16. Applicant: Jet Soft Srl.

Clearance details

Applicant: Jet Soft Srl
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-08-01
Decision date: 2012-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bucharest, RO

Download summary PDF View on FDA.gov ↗

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.