The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for 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.
| Device ID | K950914 |
| 510k Number | K950914 |
| Device Name: | 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 |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
| Contact | Karlheinz Riester |
| Correspondent | Karlheinz Riester RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-23 |
| Decision Date | 1995-07-24 |