PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)— 510(k) K960449

Substantially Equivalent

Biosensor Corp.

FDA 510(k) clearance K960449 for PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90), Substantially Equivalent on 1996-05-30. Applicant: Biosensor Corp..

Clearance details

Applicant: Biosensor Corp.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1996-01-30
Decision date: 1996-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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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.