The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Ri-mini.
| Device ID | K932503 |
| 510k Number | K932503 |
| Device Name: | RI-MINI |
| Classification | Otoscope |
| Applicant | RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
| Contact | Karlheinz Riesteer |
| Correspondent | Karlheinz Riesteer RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-21 |
| Decision Date | 1993-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396177062 | K932503 | 000 |
| 04045396011649 | K932503 | 000 |
| 04045396011618 | K932503 | 000 |
| 04045396011571 | K932503 | 000 |
| 04045396011533 | K932503 | 000 |
| 04045396011496 | K932503 | 000 |
| 04045396010598 | K932503 | 000 |
| 04045396010581 | K932503 | 000 |
| 04045396003194 | K932503 | 000 |
| 04045396002951 | K932503 | 000 |
| 04045396002913 | K932503 | 000 |
| 04045396011656 | K932503 | 000 |
| 04045396011779 | K932503 | 000 |
| 04045396177055 | K932503 | 000 |
| 04045396177048 | K932503 | 000 |
| 04045396177031 | K932503 | 000 |
| 04045396177024 | K932503 | 000 |
| 04045396176942 | K932503 | 000 |
| 04045396176935 | K932503 | 000 |
| 04045396176928 | K932503 | 000 |
| 04045396176911 | K932503 | 000 |
| 04045396176904 | K932503 | 000 |
| 04045396176881 | K932503 | 000 |
| 04045396002876 | K932503 | 000 |