Clearance Summary
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V received FDA 510(k) clearance under submission number K950914, sponsored by Rudolf Riester GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-07-24.
- Submission: K950914
- Applicant / Sponsor: Rudolf Riester GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1995-07-24
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.