The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Ri-san/ri-sana Blood Pressure Manometers.
| Device ID | K002954 |
| 510k Number | K002954 |
| Device Name: | RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS |
| 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 | 2000-09-22 |
| Decision Date | 2000-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396210141 | K002954 | 000 |
| 04045396197473 | K002954 | 000 |
| 04045396190795 | K002954 | 000 |
| 04045396174221 | K002954 | 000 |