510(k) K102389— NAVIGATOR APPLICATIONS SUITE

Substantially Equivalent

GE Healthcare Finland Oy

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2010-08-23
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.