Clearance Summary
APOLLO AIR FLUIDIZED BED received FDA 510(k) clearance under submission number K842987, sponsored by Apollo Fluid Dynamics. 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 1984-08-02.
- Submission: K842987
- Applicant / Sponsor: Apollo Fluid Dynamics
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5160
- Decision date: 1984-08-02
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.