HEMOTHERM MODEL 400— 510(k) K811742

Substantially Equivalent

Cincinnati Sub-Zero

FDA 510(k) clearance K811742 for HEMOTHERM MODEL 400, Substantially Equivalent on 1981-08-13. Applicant: Cincinnati Sub-Zero.

Clearance details

Applicant: Cincinnati Sub-Zero
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1981-06-19
Decision date: 1981-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.