GERBER NATURAL COMFORT BATTERY BREAST PUMP— 510(k) K942534

Substantially Equivalent

Gerber Products Co.

FDA 510(k) clearance K942534 for GERBER NATURAL COMFORT BATTERY BREAST PUMP, Substantially Equivalent on 1995-05-25. Applicant: Gerber Products Co..

Clearance details

Applicant: Gerber Products Co.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1994-05-27
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reedsburg, WI, US

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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.