MODEL 500V VASCULAR SPECTRUM ANALYZER— 510(k) K882755

Substantially Equivalent

Multigon Industries, Inc.

FDA 510(k) clearance K882755 for MODEL 500V VASCULAR SPECTRUM ANALYZER, Substantially Equivalent on 1988-11-29. Applicant: Multigon Industries, Inc..

Clearance details

Applicant: Multigon Industries, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1988-07-05
Decision date: 1988-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Vernon, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.