IVEX MODEL NO. BP 3000 BREASTPUMP— 510(k) K893545

Substantially Equivalent

Ivex Medical, Inc.

FDA 510(k) clearance K893545 for IVEX MODEL NO. BP 3000 BREASTPUMP, Substantially Equivalent on 1990-02-16. Applicant: Ivex Medical, Inc..

Clearance details

Applicant: Ivex Medical, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1989-05-08
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.