PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION— 510(k) K890268

Substantially Equivalent

Biomedical Dynamics, Inc.

FDA 510(k) clearance K890268 for PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION, Substantially Equivalent on 1989-05-05. Applicant: Biomedical Dynamics, Inc..

Clearance details

Applicant: Biomedical Dynamics, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1989-01-18
Decision date: 1989-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.