The following data is part of a premarket notification filed by Rud Riester Gmbh & Co Kg with the FDA for Minimus I; Minimus Iii, Sanaphon.
| Device ID | K942649 |
| 510k Number | K942649 |
| Device Name: | MINIMUS I; MINIMUS III, SANAPHON |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | RUD RIESTER GMBH & CO KG BRUCKSTR.31,P.O.BOX 35 Jungingen, DE |
| Contact | Karlheinz Riester |
| Correspondent | Karlheinz Riester RUD RIESTER GMBH & CO KG BRUCKSTR.31,P.O.BOX 35 Jungingen, DE |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396102507 | K942649 | 000 |