Clearance Summary
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES received FDA 510(k) clearance under submission number K112944, sponsored by Fresenius Medical Care South Asia Pacific Pty , Ltd.. 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 2011-12-30.
- Submission: K112944
- Applicant / Sponsor: Fresenius Medical Care South Asia Pacific Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3110
- Decision date: 2011-12-30
Classification & Regulation
This clearance is catalogued under FDA product code INO and 21 CFR 890.3110, within the Physical Medicine review panel as a Class II device.