Clearance Summary
SEP 90 received FDA 510(k) clearance under submission number K904103, sponsored by Elema-Schonander, 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 1990-11-20.
- Submission: K904103
- Applicant / Sponsor: Elema-Schonander, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1870
- Decision date: 1990-11-20
Classification & Regulation
This clearance is catalogued under FDA product code IZP and 21 CFR 892.1870, within the Radiology review panel as a Class II device.