CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE— 510(k) K111614

Substantially Equivalent

Ge Healthcare Integrated IT Solutions

FDA 510(k) clearance K111614 for CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE, Substantially Equivalent on 2011-09-26. Applicant: Ge Healthcare Integrated IT Solutions.

Clearance details

Applicant: Ge Healthcare Integrated IT Solutions
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2011-06-08
Decision date: 2011-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrington, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.