Clearance Summary
TRAM 2001 MODULE received FDA 510(k) clearance under submission number K011000, 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 2001-06-29.
- Submission: K011000
- Applicant / Sponsor: General Electric Medical Systems Information Techn
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2001-06-29
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.