Clearance Summary
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas received FDA 510(k) clearance under submission number K173591, 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 2018-03-28.
- Submission: K173591
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4330
- Decision date: 2018-03-28
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.