ARRHYTHMIA REVIEW STATION— 510(k) K854136

Name: FDA 510(k) clearance K854136
Creator: U.S. Food and Drug Administration
Published: 1985-12-04

Substantially Equivalent

Marquette Electronics, Inc.

FDA 510(k) clearance K854136 for ARRHYTHMIA REVIEW STATION, Substantially Equivalent on 1985-12-04. Applicant: Marquette Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Marquette Electronics, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1985-10-10
Decision date: 1985-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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.