Clearance Summary
KEANE MOBILITY BED received FDA 510(k) clearance under submission number K873047, 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 1987-10-15.
- Submission: K873047
- Applicant / Sponsor: Surgi-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5225
- Decision date: 1987-10-15
Classification & Regulation
This clearance is catalogued under FDA product code IKZ and 21 CFR 890.5225, within the Physical Medicine review panel as a Class II device.