ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101— 510(k) K052047

Substantially Equivalent

Avent America, Inc.

FDA 510(k) clearance K052047 for ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101, Substantially Equivalent on 2005-09-22. Applicant: Avent America, Inc..

Clearance details

Applicant: Avent America, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2005-07-29
Decision date: 2005-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, 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.