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FDA 510(k), K212657, Quantum Heater-Cooler
FDA 510(k), K212657, Quantum Heater-Cooler
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$149.00 USD
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510(K) Number: K212657
Device Name: Quantum Heater-Cooler
Manufacturer: Spectrum Medical Ltd.
Device Classification Name: Controller, Temperature, Cardiopulmonary Bypass
Regulation Number: 870.4250
Classification Product Code: DWC
Date Received: 08/23/2021
Decision Date: 05/06/2022
Regulation Medical Specialty: Cardiovascular
Device Name: Quantum Heater-Cooler
Manufacturer: Spectrum Medical Ltd.
Device Classification Name: Controller, Temperature, Cardiopulmonary Bypass
Regulation Number: 870.4250
Classification Product Code: DWC
Date Received: 08/23/2021
Decision Date: 05/06/2022
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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