Clearance Summary
GENERAL ELECTRIC AMX II received FDA 510(k) clearance under submission number K891142, sponsored by Pro-Tronics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-05-01.
- Submission: K891142
- Applicant / Sponsor: Pro-Tronics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1989-05-01
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.