Diagnostic Medical Computer

FDA 510(k) K812638 · Diagnostic Resources, Inc.

Substantially Equivalent

510(k) numberK812638

Submission

Device name
Diagnostic Medical Computer
Applicant
Diagnostic Resources, Inc.
Walker, MI, US
Received
September 15, 1981
Decision date
November 16, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1435
Specialty
Cardiovascular

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More from Lidco, Ltd.

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K914550Antinuclear Antibody Immunoglobulin Test SystemLKJ · Traditional 02/11/1992SE
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Questions and answers

When was Diagnostic Medical Computer cleared by the FDA?

Diagnostic Medical Computer (K812638) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 62 days after the submission was received.

What is the product code of K812638?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.