DIGITAL MEDIA CONVERTER (D-MC)— 510(k) K935026

Clearance details

Applicant

Eigen Video

Product code

Code IZI

Device class

Class 2

Regulation

21 CFR 892.1600

Advisory panel

Radiology

Date received

1993-10-20

Decision date

1994-08-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Nevada City, CA, US

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Death

9

Malfunction

5,312

Total

5,321

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 →