NAVIGATOR APPLICATIONS SUITE— 510(k) K071097

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K071097 for NAVIGATOR APPLICATIONS SUITE, Substantially Equivalent on 2007-10-10. Applicant: GE Healthcare Finland Oy.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2007-04-18
Decision date: 2007-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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.