510(k) K212955— Fit Pro Breast Pump

Substantially Equivalent

Hygeia II Medical Group, Inc.

Clearance details

Applicant: Hygeia II Medical Group, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2021-09-16
Decision date: 2022-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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.