K233136
- 510(k) number
- K233136
- Device name
- Hygeia Express Powered Breast Pump
- Applicant
- Hygeia II Medical Group, Inc. CA · US
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2024-03-13
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K233136.pdf
Official FDA record: K233136
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.