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 |