Clearance Summary
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN received FDA 510(k) clearance under submission number K123216, sponsored by Aimago SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-02-07.
- Submission: K123216
- Applicant / Sponsor: Aimago SA
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2120
- Decision date: 2013-02-07
Classification & Regulation
This clearance is catalogued under FDA product code DPT and 21 CFR 870.2120, within the Cardiovascular review panel as a Class II device.