510(k) K151650— SMARTez elastomeric infusion pump

Substantially Equivalent

Epic Medical Pte. , Ltd.

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2015-06-18
Decision date: 2016-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

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.