Clearance Summary
CARDIOCAP II(TM) received FDA 510(k) clearance under submission number K912530, sponsored by Datex Medical Instrumentation, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-09-05.
- Submission: K912530
- Applicant / Sponsor: Datex Medical Instrumentation, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1991-09-05
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.