Clearance Summary
Quantum Ventilation Module received FDA 510(k) clearance under submission number K181942, 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 2018-10-18.
- Submission: K181942
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4300
- Decision date: 2018-10-18
Classification & Regulation
This clearance is catalogued under FDA product code DTX and 21 CFR 870.4300, within the Cardiovascular review panel as a Class II device.