IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD— 510(k) K913658

Substantially Equivalent

Imed Corp.

FDA 510(k) clearance K913658 for IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD, Substantially Equivalent on 1992-03-26. Applicant: Imed Corp..

Clearance details

Applicant: Imed Corp.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 1991-07-29
Decision date: 1992-03-26
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.