The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for H5000, H5000l, H5000l Reverse Model H5000c, H5000cg.
| Device ID | K946043 |
| 510k Number | K946043 |
| Device Name: | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG |
| Classification | Otoscope |
| 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 | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-12 |
| Decision Date | 1995-03-08 |