MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM— 510(k) K032772

Substantially Equivalent

Hill-Rom Manufacturing, Inc.

FDA 510(k) clearance K032772 for MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM, Substantially Equivalent on 2003-10-08. Applicant: Hill-Rom Manufacturing, Inc..

Clearance details

Applicant
Hill-Rom Manufacturing, Inc.
Product code
Code HGM
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Cary, NC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HGM

product code HGM
Death
35
Malfunction
478
Total
513

Source: openFDA MAUDE database, through . 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.