K052190

Substantially Equivalent

FETAL MONITOR, MODELS BT-300 AND BT-200

Applicant: Bistos Co., Ltd.
Product code: HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2005-08-11
Decision date: 2005-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flintville, TN, 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.