Clearance Summary
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K070395, sponsored by Kodon(Tianjin)Electronic&Electrical Apparatus Co.,. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-06-07.
- Submission: K070395
- Applicant / Sponsor: Kodon(Tianjin)Electronic&Electrical Apparatus Co.,
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2007-06-07
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.