NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912— 510(k) K080226

Substantially Equivalent

Hill-Rom Manufacturing, Inc.

FDA 510(k) clearance K080226 for NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912, Substantially Equivalent on 2008-04-09. Applicant: Hill-Rom Manufacturing, Inc..

Clearance details

Applicant: Hill-Rom Manufacturing, Inc.
Product code: 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

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.