DIB INFUSOR— 510(k) K930404

Name: FDA 510(k) clearance K930404
Creator: U.S. Food and Drug Administration
Published: 1994-02-25

Substantially Equivalent

Novacon Corp.

FDA 510(k) clearance K930404 for DIB INFUSOR, Substantially Equivalent on 1994-02-25. Applicant: Novacon Corp.. Device class: 2.

Clearance details

Applicant: Novacon Corp.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1993-01-26
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K944665 — DIB INFUSORS1995-02-14
K941766 — DIB INFUSOR1994-08-05

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.