Clearance Summary
BPFONE, MODEL UA 767IT received FDA 510(k) clearance under submission number K010751, sponsored by Medical Monitors Pty Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-06-11.
- Submission: K010751
- Applicant / Sponsor: Medical Monitors Pty Limited
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2001-06-11
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.