Clearance Summary
ATLANT'S received FDA 510(k) clearance under submission number K974395, sponsored by Grad-Line Corp.. 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 1998-10-22.
- Submission: K974395
- Applicant / Sponsor: Grad-Line Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 1998-10-22
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.