imani i1— 510(k) K202045

Substantially Equivalent

Imani Co.

FDA 510(k) clearance K202045 for imani i1, Substantially Equivalent on 2021-02-26. Applicant: Imani Co..

Clearance details

Applicant: Imani Co.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2020-07-23
Decision date: 2021-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

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.