DIAGNOSTIC MEDICAL COMPUTER— 510(k) K812638

Name: FDA 510(k) clearance K812638
Creator: U.S. Food and Drug Administration
Published: 1981-11-16

Substantially Equivalent

Diagnostic Resources, Inc.

FDA 510(k) clearance K812638 for DIAGNOSTIC MEDICAL COMPUTER, Substantially Equivalent on 1981-11-16. Applicant: Diagnostic Resources, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Resources, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1981-09-15
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.