Clearance Summary
GE CT/T MODEL NO. B7800 A received FDA 510(k) clearance under submission number K760882, sponsored by Arnold & Porter For G.E. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1976-11-19.
- Submission: K760882
- Applicant / Sponsor: Arnold & Porter For G.E. Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 1976-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.