K960553

Substantially Equivalent

CARD GUARD MODEL CG-900

Applicant: Card Guard Scientific Survival , Ltd.
Product code: HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1996-02-08
Decision date: 1997-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malibu, CA, US

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.