PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX— 510(k) K020550

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K020550 for PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX, Substantially Equivalent on 2002-08-28. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2002-02-19
Decision date: 2002-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwh, NJ, US

Download summary PDF View on FDA.gov ↗

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.