NIO COLOR 3MP AND MDNC 3120— 510(k) K070726

Substantially Equivalent

Barcoview, Medical Imaging Systems

FDA 510(k) clearance K070726 for NIO COLOR 3MP AND MDNC 3120, Substantially Equivalent on 2007-05-02. Applicant: Barcoview, Medical Imaging Systems.

Clearance details

Applicant
Barcoview, Medical Imaging Systems
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kortrijk, BE
Download summary PDFView on FDA.gov ↗

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.