Quantum Heater-Cooler
K-Number: K212657 · 2022-05-06
ApplicantSpectrum Medical , Ltd.
Decision Date2022-05-06
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Quantum Heater-Cooler is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2022-05-06 under approval number K212657. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantum Heater-Cooler?
Quantum Heater-Cooler is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K212657.
When was Quantum Heater-Cooler approved by the FDA?
Quantum Heater-Cooler received FDA 510(k) clearance on 2022-05-06, under approval number K212657.
What company makes Quantum Heater-Cooler?
Quantum Heater-Cooler is manufactured by Spectrum Medical , Ltd..
What is the FDA product code for Quantum Heater-Cooler?
The FDA product code for Quantum Heater-Cooler is DWC.
Other Devices by Spectrum Medical , Ltd.
Related Devices (Code: DWC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.