Clearance Summary
ROTA SYSTEM XL received FDA 510(k) clearance under submission number K931839, sponsored by Rota Systems Medfurniture, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1993-11-22.
- Submission: K931839
- Applicant / Sponsor: Rota Systems Medfurniture, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1860
- Decision date: 1993-11-22
Classification & Regulation
This clearance is catalogued under FDA product code HMF and 21 CFR 886.1860, within the Ophthalmic review panel as a Class I device.