K844401

Substantially Equivalent

REPRO-MED SYSTEMS INFUSION DEVICE

Applicant: Repro-Med Systems, Inc.
Product code: FRN
Advisory panel: General Hospital
Date received: 1984-11-13
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middletown, NY, US

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.