The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Big Ben Square, Big Ben Round.
| Device ID | K972301 |
| 510k Number | K972301 |
| Device Name: | BIG BEN SQUARE, BIG BEN ROUND |
| 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 | 1997-06-19 |
| Decision Date | 1997-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396216860 | K972301 | 000 |
| 04045396102668 | K972301 | 000 |
| 04045396102675 | K972301 | 000 |
| 04045396102705 | K972301 | 000 |
| 04045396102736 | K972301 | 000 |
| 04045396139206 | K972301 | 000 |
| 04045396139213 | K972301 | 000 |
| 04045396146853 | K972301 | 000 |
| 04045396146907 | K972301 | 000 |
| 04045396147744 | K972301 | 000 |
| 04045396176799 | K972301 | 000 |
| 04045396211049 | K972301 | 000 |
| 04045396102651 | K972301 | 000 |