The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Ri-mega.
| Device ID | K972377 |
| 510k Number | K972377 |
| Device Name: | RI-MEGA |
| Classification | Blood Pressure Cuff |
| Applicant | RUDOLF RIESTER GMBH & CO. KG BRUCKSTRASSE 31 P.O. BOX 35 Jungingen, DE D-72417 |
| Contact | Patricia Riester Freudenmann |
| Correspondent | Patricia Riester Freudenmann RUDOLF RIESTER GMBH & CO. KG BRUCKSTRASSE 31 P.O. BOX 35 Jungingen, DE D-72417 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-09-24 |