Clearance Summary
CARDIODIRECT, MODELS 12M, 12I, 12S received FDA 510(k) clearance under submission number K024283, sponsored by Reynolds Medical , 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 2003-08-01.
- Submission: K024283
- Applicant / Sponsor: Reynolds Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2003-08-01
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.