INFUSION DYNAMICS POWER INFUSER— 510(k) K974074

Name: FDA 510(k) clearance K974074
Creator: U.S. Food and Drug Administration
Published: 1998-02-17

Substantially Equivalent

Infusion Dynamics, Inc.

FDA 510(k) clearance K974074 for INFUSION DYNAMICS POWER INFUSER, Substantially Equivalent on 1998-02-17. Applicant: Infusion Dynamics, Inc.. Device class: 1.

Clearance details

Applicant: Infusion Dynamics, Inc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1997-10-29
Decision date: 1998-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.