INFUSABLE— 510(k) K911216

Substantially Equivalent

Biomedical Dynamics, Inc.

FDA 510(k) clearance K911216 for INFUSABLE, Substantially Equivalent on 1991-07-22. Applicant: Biomedical Dynamics, Inc..

Clearance details

Applicant: Biomedical Dynamics, Inc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1991-03-19
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, US

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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.