SINGLE USE LEE ELECTRODE— 510(k) K912046

Substantially Equivalent

Aspen Labs

FDA 510(k) clearance K912046 for SINGLE USE LEE ELECTRODE, Substantially Equivalent on 1992-03-05. Applicant: Aspen Labs.

Clearance details

Applicant: Aspen Labs
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1991-05-08
Decision date: 1992-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGI

product code HGI

Other: 1
Total: 1

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.