Quantum Heater-Cooler— 510(k) K212657

Substantially Equivalent

Spectrum Medical , Ltd.

FDA 510(k) clearance K212657 for Quantum Heater-Cooler, Substantially Equivalent on 2022-05-06. Applicant: Spectrum Medical , Ltd..

Clearance details

Applicant: Spectrum Medical , Ltd.
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 2021-08-23
Decision date: 2022-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

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.