Clearance Summary
HYDRAULIC IV POLE received FDA 510(k) clearance under submission number K893597, sponsored by Arthro-Medic, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1989-10-10.
- Submission: K893597
- Applicant / Sponsor: Arthro-Medic, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6990
- Decision date: 1989-10-10
Classification & Regulation
This clearance is catalogued under FDA product code FOX and 21 CFR 880.6990, within the General Hospital review panel as a Class I device.