Clearance Summary
XM-01 Electronic Automatic Blood Pressure Monitor received FDA 510(k) clearance under submission number K150908, sponsored by Sky Innovation Technology ( Shanghai) Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-12-16.
- Submission: K150908
- Applicant / Sponsor: Sky Innovation Technology ( Shanghai) Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2015-12-16
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.