AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10— 510(k) K993832

Substantially Equivalent

Tandem Medical, Inc.

FDA 510(k) clearance K993832 for AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10, Substantially Equivalent on 2000-02-09. Applicant: Tandem Medical, Inc..

Clearance details

Applicant: Tandem Medical, Inc.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 1999-11-12
Decision date: 2000-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.