Clearance Summary
Quantum Workstation 12 Elite received FDA 510(k) clearance under submission number K202557, sponsored by Spectrum Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-10-02.
- Submission: K202557
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4330
- Decision date: 2020-10-02
Classification & Regulation
This clearance is catalogued under FDA product code DRY and 21 CFR 870.4330, within the Cardiovascular review panel as a Class II device.