BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR— 510(k) K861977

Substantially Equivalent

Biomedical Dynamics, Inc.

FDA 510(k) clearance K861977 for BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR, Substantially Equivalent on 1986-07-15. Applicant: Biomedical Dynamics, Inc..

Clearance details

Applicant: Biomedical Dynamics, Inc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1986-05-21
Decision date: 1986-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.