Clearance Summary
ARJO-CENTURY ARM AND LEG TANK SYSTEM received FDA 510(k) clearance under submission number K923637, sponsored by Arjo-Century, 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 1993-02-12.
- Submission: K923637
- Applicant / Sponsor: Arjo-Century, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5100
- Decision date: 1993-02-12
Classification & Regulation
This clearance is catalogued under FDA product code ILJ and 21 CFR 890.5100, within the Physical Medicine review panel as a Class II device.