EURO SC500— 510(k) K944940

Substantially Equivalent

Pride Health Care, Inc.

FDA 510(k) clearance K944940 for EURO SC500, Substantially Equivalent on 1996-02-12. Applicant: Pride Health Care, Inc..

Clearance details

Applicant: Pride Health Care, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1994-10-07
Decision date: 1996-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Wyoming, PA, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.