TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI— 510(k) K850746

Substantially Equivalent

Tri-Med, Inc.

FDA 510(k) clearance K850746 for TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI, Substantially Equivalent on 1985-04-02. Applicant: Tri-Med, Inc..

Clearance details

Applicant: Tri-Med, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1985-02-25
Decision date: 1985-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.