Clearance Summary
NAVIGATOR CLINICAL GUIDENCE SYSTEM received FDA 510(k) clearance under submission number K092219, sponsored by Applied Physiology Pty , 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 2010-05-12.
- Submission: K092219
- Applicant / Sponsor: Applied Physiology Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 2010-05-12
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.