Direct Writing Vectorcardiograph

FDA 510(k) K810529 · Elmed, Inc.

Substantially Equivalent

510(k) numberK810529

Submission

Device name
Direct Writing Vectorcardiograph
Applicant
Elmed, Inc.
Mchenry, IL, US
Received
February 26, 1981
Decision date
April 23, 1981
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

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Questions and answers

When was Direct Writing Vectorcardiograph cleared by the FDA?

Direct Writing Vectorcardiograph (K810529) received a 510(k) decision of Substantially Equivalent on April 23, 1981, 56 days after the submission was received.

What is the product code of K810529?

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