Clearance Summary
THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 received FDA 510(k) clearance under submission number K051861, sponsored by Savion Industries, Ltd.. 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 2005-09-28.
- Submission: K051861
- Applicant / Sponsor: Savion Industries, Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3690
- Decision date: 2005-09-28
Classification & Regulation
This clearance is catalogued under FDA product code INK and 21 CFR 890.3690, within the Physical Medicine review panel as a Class II device.