IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM— 510(k) K870934

Name: FDA 510(k) clearance K870934
Creator: U.S. Food and Drug Administration
Published: 1987-05-06

Substantially Equivalent

Integrated Medical Systems, Inc.

FDA 510(k) clearance K870934 for IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM, Substantially Equivalent on 1987-05-06. Applicant: Integrated Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Integrated Medical Systems, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1987-03-09
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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