Clearance Summary
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K052450, 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 2006-02-28.
- Submission: K052450
- 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: 2006-02-28
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.