HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP— 510(k) K033054

Substantially Equivalent

Harvard Clinical Technology

FDA 510(k) clearance K033054 for HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP, Substantially Equivalent on 2003-12-16. Applicant: Harvard Clinical Technology.

Clearance details

Applicant: Harvard Clinical Technology
Product code: Code MEA
Advisory panel: General Hospital
Date received: 2003-09-29
Decision date: 2003-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Natick, MA, 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.