K080226

Substantially Equivalent

NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912

Applicant: Hill-Rom Manufacturing, Inc.
Product code: HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2008-01-29
Decision date: 2008-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Cary, NC, US

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.