P.A.T. SYSTEM— 510(k) K943035

Substantially Equivalent

Mathews Assoc., Inc.

FDA 510(k) clearance K943035 for P.A.T. SYSTEM, Substantially Equivalent on 1994-10-04. Applicant: Mathews Assoc., Inc..

Clearance details

Applicant: Mathews Assoc., Inc.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1994-06-27
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanford, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

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.