WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)— 510(k) K121669

Substantially Equivalent

Cincinnati Sub-Zero Products, Inc.

FDA 510(k) clearance K121669 for WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS), Substantially Equivalent on 2012-07-03. Applicant: Cincinnati Sub-Zero Products, Inc..

Clearance details

Applicant: Cincinnati Sub-Zero Products, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2012-06-06
Decision date: 2012-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Sharonville, OH, 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.