Clearance Summary
SEP PROGRAMMER SEP-M/SINGLE-PLANE & received FDA 510(k) clearance under submission number K840389, 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 1984-02-21.
- Submission: K840389
- Applicant / Sponsor: Elema-Schonander, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1870
- Decision date: 1984-02-21
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.