Clearance Summary
7500 DATA TOWER received FDA 510(k) clearance under submission number K935498, sponsored by E-Systems, 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 1994-04-01.
- Submission: K935498
- Applicant / Sponsor: E-Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.2010
- Decision date: 1994-04-01
Classification & Regulation
This clearance is catalogued under FDA product code LMB and 21 CFR 892.2010, within the Radiology review panel as a Class I device.