Clearance Summary
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET received FDA 510(k) clearance under submission number K043437, sponsored by Health & Life Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-01-12.
- Submission: K043437
- Applicant / Sponsor: Health & Life Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2005-01-12
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.