Clearance Summary
ULTRACHECK CURVE BLOOD PRESSURE CUFFS received FDA 510(k) clearance under submission number K122365, sponsored by Statcorp Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-06-04.
- Submission: K122365
- Applicant / Sponsor: Statcorp Medical
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2013-06-04
Classification & Regulation
This clearance is catalogued under FDA product code OED and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.