Clearance Summary
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 received FDA 510(k) clearance under submission number K011310, sponsored by Nien Made Electrnics Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-07-20.
- Submission: K011310
- Applicant / Sponsor: Nien Made Electrnics Corp.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2001-07-20
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.