Clearance Summary
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 received FDA 510(k) clearance under submission number K092683, sponsored by Shanghai Little Doctor Co. Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-09-25.
- Submission: K092683
- Applicant / Sponsor: Shanghai Little Doctor Co. Limited
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2009-09-25
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.