Clearance Summary
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 received FDA 510(k) clearance under submission number K070156, sponsored by Cardiodynamics International Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-09-26.
- Submission: K070156
- Applicant / Sponsor: Cardiodynamics International Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2007-09-26
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.