K914921

Substantially Equivalent

SCM-3 AND ACCESSORIES

Applicant: Gaymar Industries, Inc.
Product code: IKY
Advisory panel: General Hospital
Date received: 1991-11-04
Decision date: 1992-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Adverse events under product code IKY

product code IKY

Death: 5
Malfunction: 491
Other: 4
Total: 500

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.