Mida System, Models 1000/1100

FDA 510(k) K896396 · Medical Graphics Corp.

Substantially Equivalent

510(k) numberK896396

Submission

Device name
Mida System, Models 1000/1100
Applicant
Medical Graphics Corp.
Findley, MN, US
Received
November 6, 1989
Decision date
January 18, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DYC – Vectorcardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2400
Specialty
Cardiovascular

Other 510(k)s with product code DYC

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K023414Mida Algorithm Rev. BDYC · Traditional Ortivus AB12/05/2003SE
K823934Cariel F12DYC · Traditional Odam12/16/1983SE
K810529Direct Writing VectorcardiographDYC · Traditional Elmed, Inc.04/23/1981SE

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Questions and answers

When was Mida System, Models 1000/1100 cleared by the FDA?

Mida System, Models 1000/1100 (K896396) received a 510(k) decision of Substantially Equivalent on January 18, 1990, 73 days after the submission was received.

What is the product code of K896396?

The FDA product code is DYC – Vectorcardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2400.