Clearance Summary
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM received FDA 510(k) clearance under submission number K001305, sponsored by General Electric Medical Systems Information Techn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-06-27.
- Submission: K001305
- Applicant / Sponsor: General Electric Medical Systems Information Techn
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2000-06-27
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.