Q4000 OPTION FOR Q4000— 510(k) K882978

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K882978 for Q4000 OPTION FOR Q4000, Substantially Equivalent on 1988-11-01. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1988-07-15
Decision date: 1988-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.