Digital Media Converter (D-Mc)

Q: What is the product code of K935026?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.

FDA 510(k) K935026 · Eigen Video

Substantially Equivalent

510(k) numberK935026

Submission

Device name: Digital Media Converter (D-Mc)
Applicant: Eigen Video
Nevada City, CA, US
Received: October 20, 1993
Decision date: August 24, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IZI – System, X-Ray, Angiographic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1600
Specialty: Radiology

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Questions and answers

When was Digital Media Converter (D-Mc) cleared by the FDA?

Digital Media Converter (D-Mc) (K935026) received a 510(k) decision of Substantially Equivalent on August 24, 1994, 308 days after the submission was received.

What is the product code of K935026?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.