HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM— 510(k) K122813

Substantially Equivalent

Cincinnati Sub-Zero Products, Inc.

FDA 510(k) clearance K122813 for HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM, Substantially Equivalent on 2012-12-18. Applicant: Cincinnati Sub-Zero Products, Inc..

Clearance details

Applicant: Cincinnati Sub-Zero Products, Inc.
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 2012-09-13
Decision date: 2012-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sharonville, OH, US

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.