FDA 510(k) Applications Submitted by Colleen Powell

FDA 510(k) Number Submission Date Device Name Applicant
K190282 02/11/2019 Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) Spectrum Medical Ltd
K210669 03/05/2021 Quantum Mini Ventilation Module Spectrum Medical Ltd.
K181923 07/18/2018 Quantum Workstation 12.1 Spectrum Medical Ltd
K212657 08/23/2021 Quantum Heater-Cooler Spectrum Medical Ltd.
K202557 09/03/2020 Quantum Workstation 12 Elite Spectrum Medical Ltd
K202733 09/18/2020 Quantum Ventilation Module Spectrum Medical Ltd
K192838 10/03/2019 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure Spectrum Medical Ltd


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