Clearance Summary
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 received FDA 510(k) clearance under submission number K014204, sponsored by K-Jump Health Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-03-05.
- Submission: K014204
- Applicant / Sponsor: K-Jump Health Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2002-03-05
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.