MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE— 510(k) K854734

Substantially Equivalent

Medasonics, Inc.

FDA 510(k) clearance K854734 for MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE, Substantially Equivalent on 1986-02-10. Applicant: Medasonics, Inc..

Clearance details

Applicant: Medasonics, Inc.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 1985-11-25
Decision date: 1986-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.