BIO-MEDICUS BIO CONSOLE MODELS 540 A B C— 510(k) K901584

Substantially Equivalent

Bio Medicus, Inc.

FDA 510(k) clearance K901584 for BIO-MEDICUS BIO CONSOLE MODELS 540 A B C, Substantially Equivalent on 1990-06-28. Applicant: Bio Medicus, Inc..

Clearance details

Applicant: Bio Medicus, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 1990-04-04
Decision date: 1990-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.