Clearance Summary
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K023356, sponsored by Card Guard Scientific Survival , 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 2003-01-16.
- Submission: K023356
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2003-01-16
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.