510(k) K991786— MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION

Substantially Equivalent

General Electric Medical Systems Information Techn

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1999-05-25
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.