DIB INFUSOR— 510(k) K941766

Substantially Equivalent - Subject to Tracking Reg.

Novacon Corp.

FDA 510(k) clearance K941766 for DIB INFUSOR, Substantially Equivalent - Subject to Tracking Reg. on 1994-08-05. Applicant: Novacon Corp..

Clearance details

Applicant: Novacon Corp.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 1994-04-11
Decision date: 1994-08-05
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: St.Paul, MN, 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.