HEATER COOLER UNIT, MODEL HCU 30— 510(k) K031544

Substantially Equivalent

Jostra AB

FDA 510(k) clearance K031544 for HEATER COOLER UNIT, MODEL HCU 30, Substantially Equivalent on 2003-08-07. Applicant: Jostra AB.

Clearance details

Applicant: Jostra AB
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 2003-05-16
Decision date: 2003-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Woodlands, TX, 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.