Clearance Summary
DELTANODE, MEGA DELTA, DELTA LINK- received FDA 510(k) clearance under submission number K843558, sponsored by Computer Design & Applications, 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 1984-11-13.
- Submission: K843558
- Applicant / Sponsor: Computer Design & Applications, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1984-11-13
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.