STAT-SAT— 510(k) K874839

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K874839 for STAT-SAT, Substantially Equivalent on 1988-05-13. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1987-11-24
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.