B40i Patient Monitor— 510(k) K143676

Substantially Equivalent

GE Healthcare Finland Oy

FDA 510(k) clearance K143676 for B40i Patient Monitor, Substantially Equivalent on 2015-07-31. Applicant: GE Healthcare Finland Oy.

Clearance details

Applicant: GE Healthcare Finland Oy
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2014-12-24
Decision date: 2015-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.