Clearance Summary
ASSISTO ARM SYSTEMS received FDA 510(k) clearance under submission number K052745, sponsored by Geomed Medizin-Technik GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-11-23.
- Submission: K052745
- Applicant / Sponsor: Geomed Medizin-Technik GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 2005-11-23
Classification & Regulation
This clearance is catalogued under FDA product code GWG and 21 CFR 882.1480, within the Neurology review panel as a Class II device.