Clearance Summary
ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. received FDA 510(k) clearance under submission number K893476, sponsored by Andros Analyzers, 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 1989-06-23.
- Submission: K893476
- Applicant / Sponsor: Andros Analyzers, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1989-06-23
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.