K200675

Substantially Equivalent

Hi bebe super (Models BT-150S and BT-150L)

Applicant: Bistos Co., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2020-03-16
Decision date: 2021-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Si, KR

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.