BIO-CAL 370 HEATER/COOLER— 510(k) K894980

Substantially Equivalent

Bio Medicus, Inc.

FDA 510(k) clearance K894980 for BIO-CAL 370 HEATER/COOLER, Substantially Equivalent on 1989-11-02. Applicant: Bio Medicus, Inc..

Clearance details

Applicant: Bio Medicus, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1989-08-08
Decision date: 1989-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.