LOOP/SQUARE ELECTRODE— 510(k) K952030

Substantially Equivalent

E & M Engineering, Inc.

FDA 510(k) clearance K952030 for LOOP/SQUARE ELECTRODE, Substantially Equivalent on 1996-07-31. Applicant: E & M Engineering, Inc..

Clearance details

Applicant: E & M Engineering, Inc.
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1995-05-01
Decision date: 1996-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, 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.