MEDIVAC— 510(k) K924577

Substantially Equivalent

Medisonic U.S.A., Inc.

FDA 510(k) clearance K924577 for MEDIVAC, Substantially Equivalent on 1993-03-23. Applicant: Medisonic U.S.A., Inc..

Clearance details

Applicant: Medisonic U.S.A., Inc.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1992-09-10
Decision date: 1993-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, US

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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.