MICROMED PD-8K INSULATION DEFECT DETECTOR— 510(k) K101606

Substantially Equivalent

Mcgan Technology, LLC

FDA 510(k) clearance K101606 for MICROMED PD-8K INSULATION DEFECT DETECTOR, Substantially Equivalent on 2010-10-01. Applicant: Mcgan Technology, LLC.

Clearance details

Applicant: Mcgan Technology, LLC
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 2010-06-08
Decision date: 2010-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middletown, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HFG

product code HFG

Death: 3
Injury: 121
Total: 124

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.