LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP— 510(k) K971543

Substantially Equivalent

Kaweco GmbH

FDA 510(k) clearance K971543 for LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP, Substantially Equivalent on 1997-09-18. Applicant: Kaweco GmbH.

Clearance details

Applicant: Kaweco GmbH
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1997-04-28
Decision date: 1997-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, 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.