GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300— 510(k) K940009

Substantially Equivalent

General Devices

FDA 510(k) clearance K940009 for GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300, Substantially Equivalent on 1995-04-14. Applicant: General Devices.

Clearance details

Applicant: General Devices
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1994-01-04
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.