imani i2Plus Breast Pump— 510(k) K222573

Substantially Equivalent

Imani Co.

FDA 510(k) clearance K222573 for imani i2Plus Breast Pump, Substantially Equivalent on 2023-03-03. Applicant: Imani Co..

Clearance details

Applicant: Imani Co.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2022-08-25
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, CN

Download summary PDF View on FDA.gov ↗

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.