Clearance Summary
LOGIC 3 ELECTROCARDIOGRAPH received FDA 510(k) clearance under submission number K882472, sponsored by Cel-Med Co., 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 1988-11-17.
- Submission: K882472
- Applicant / Sponsor: Cel-Med Co., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1988-11-17
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.