The following data is part of a premarket notification filed by Rudolf Riester Gmbh with the FDA for Oscillometric Blood Pressure Monitor.
| Device ID | K190927 |
| 510k Number | K190927 |
| Device Name: | Oscillometric Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Rudolf Riester GmbH P.O. Box 35 Bruckstrasse 31 Jungingen, DE D-72417 |
| Contact | Vivi Ding |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-09 |
| Decision Date | 2019-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396214590 | K190927 | 000 |
| 04045396208971 | K190927 | 000 |
| 04045396208858 | K190927 | 000 |
| 04045396208797 | K190927 | 000 |