Clearance Summary
Handheld VitalSigns Monitoring System received FDA 510(k) clearance under submission number K172965, sponsored by Visiomed Technology Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-12-17.
- Submission: K172965
- Applicant / Sponsor: Visiomed Technology Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2018-12-17
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.