FREEMIE BREAST COLLECTION SYSTEM— 510(k) K130349

Substantially Equivalent

Dao Health

FDA 510(k) clearance K130349 for FREEMIE BREAST COLLECTION SYSTEM, Substantially Equivalent on 2013-09-06. Applicant: Dao Health.

Clearance details

Applicant: Dao Health
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2013-02-12
Decision date: 2013-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: California, CA, US

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.