ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST— 510(k) K914206

Name: FDA 510(k) clearance K914206
Creator: U.S. Food and Drug Administration
Published: 1992-03-30

Substantially Equivalent

Kardiosis Ltd. Co.

FDA 510(k) clearance K914206 for ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST, Substantially Equivalent on 1992-03-30. Applicant: Kardiosis Ltd. Co.. Device class: 2.

Clearance details

Applicant: Kardiosis Ltd. Co.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1991-09-19
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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