K121208

Substantially Equivalent

OBIX PERINATAL DATA SYSTEM 7.0

Applicant: Clinical Computer Systems, Inc.
Product code: HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2012-04-20
Decision date: 2012-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elgin, IL, 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.