AXICARE BREAST PUMP MODEL— 510(k) K811403

Substantially Equivalent

Neonatal Corp.

FDA 510(k) clearance K811403 for AXICARE BREAST PUMP MODEL, Substantially Equivalent on 1981-06-12. Applicant: Neonatal Corp..

Clearance details

Applicant: Neonatal Corp.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1981-05-18
Decision date: 1981-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.