EXPRESSE AND PREMIER POWERED BREAST PUMPS— 510(k) K973501

Substantially Equivalent

Ameda Medizintechnik AG

FDA 510(k) clearance K973501 for EXPRESSE AND PREMIER POWERED BREAST PUMPS, Substantially Equivalent on 1997-12-11. Applicant: Ameda Medizintechnik AG.

Clearance details

Applicant: Ameda Medizintechnik AG
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1997-09-16
Decision date: 1997-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, 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.