Clearance Summary
QUINTON Q-TE; RMS received FDA 510(k) clearance under submission number K041607, sponsored by Quinton Cardiology, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-07-16.
- Submission: K041607
- Applicant / Sponsor: Quinton Cardiology, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2004-07-16
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.