PLUS 1— 510(k) K850478

Substantially Equivalent

Dymax Corp

FDA 510(k) clearance K850478 for PLUS 1, Substantially Equivalent on 1985-04-15. Applicant: Dymax Corp.

Clearance details

Applicant: Dymax Corp
Product code: Code IYO
Advisory panel: Radiology
Date received: 1985-02-11
Decision date: 1985-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.