The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for H 5100, H 5200, H 5300.
| Device ID | K945507 |
| 510k Number | K945507 |
| Device Name: | H 5100, H 5200, H 5300 |
| Classification | Device, Medical Examination, Ac 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 | KZF |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1994-12-09 |