The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Uni Ii.
| Device ID | K925756 |
| 510k Number | K925756 |
| Device Name: | UNI II |
| 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 | 1992-11-13 |
| Decision Date | 1993-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396127074 | K925756 | 000 |
| 04045396010239 | K925756 | 000 |
| 04045396002746 | K925756 | 000 |