DASH 1000 PATIENT MONITOR— 510(k) K970545

Substantially Equivalent

Marquette Medical Systems, Inc.

FDA 510(k) clearance K970545 for DASH 1000 PATIENT MONITOR, Substantially Equivalent on 1997-05-08. Applicant: Marquette Medical Systems, Inc..

Clearance details

Applicant: Marquette Medical Systems, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1997-02-12
Decision date: 1997-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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.