Clearance Summary
Quantum Heater-Cooler received FDA 510(k) clearance under submission number K212657, sponsored by Spectrum Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-05-06.
- Submission: K212657
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4250
- Decision date: 2022-05-06
Classification & Regulation
This clearance is catalogued under FDA product code DWC and 21 CFR 870.4250, within the Cardiovascular review panel as a Class II device.