Clearance Summary
DIOBEAM 830 received FDA 510(k) clearance under submission number K031499, sponsored by Soft-Core Texas, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2003-09-16.
- Submission: K031499
- Applicant / Sponsor: Soft-Core Texas, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2003-09-16
Classification & Regulation
This clearance is catalogued under FDA product code NHN and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.