PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX— 510(k) K993531

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K993531 for PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX, Substantially Equivalent on 2000-01-13. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1999-10-18
Decision date: 2000-01-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Paramus, NJ, 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.