SYNDEO PCA SYRINGE PUMP, MODEL 2L3113— 510(k) K031566

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K031566 for SYNDEO PCA SYRINGE PUMP, MODEL 2L3113, Substantially Equivalent on 2003-08-19. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code MEA
Advisory panel: General Hospital
Date received: 2003-05-19
Decision date: 2003-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield Lake, IL, US

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Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.