Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62— 510(k) K203383

Substantially Equivalent

Philips Consumer Lifestyle - Innovation Site Eindhoven

FDA 510(k) clearance K203383 for Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62, Substantially Equivalent on 2020-12-15. Applicant: Philips Consumer Lifestyle - Innovation Site Eindhoven.

Clearance details

Applicant: Philips Consumer Lifestyle - Innovation Site Eindhoven
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2020-11-17
Decision date: 2020-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Eindhoven, NL

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.