The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Ri-tiniscope-slit/ri-tiniscope Spot/ri-vision-slit/ri-vision-spot.
| Device ID | K964338 |
| 510k Number | K964338 |
| Device Name: | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT |
| Classification | Retinoscope, Battery-powered |
| Applicant | RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
| Contact | Patricia Riester-freudenmann |
| Correspondent | Patricia Riester-freudenmann RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
| Product Code | HKM |
| CFR Regulation Number | 886.1780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396182783 | K964338 | 000 |
| 04045396182660 | K964338 | 000 |
| 04045396182646 | K964338 | 000 |
| 04045396140974 | K964338 | 000 |
| 04045396129931 | K964338 | 000 |
| 04045396010819 | K964338 | 000 |