Clearance Summary
MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM received FDA 510(k) clearance under submission number K881705, sponsored by Surgi-Med, 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 1988-07-13.
- Submission: K881705
- Applicant / Sponsor: Surgi-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5160
- Decision date: 1988-07-13
Classification & Regulation
This clearance is catalogued under FDA product code INX and 21 CFR 890.5160, within the Physical Medicine review panel as a Class II device.