Clearance Summary
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 received FDA 510(k) clearance under submission number K010190, sponsored by Rossmax Internationl , 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 2001-02-08.
- Submission: K010190
- Applicant / Sponsor: Rossmax Internationl , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2001-02-08
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.