PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601— 510(k) K032038

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K032038 for PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601, Substantially Equivalent on 2003-09-05. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2003-07-01
Decision date: 2003-09-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bothell, WA, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.