The following data is part of a premarket notification filed by Rudolf Riester Gmbh with the FDA for Rvs-100 Vital Signs Monitor.
| Device ID | K170538 |
| 510k Number | K170538 |
| Device Name: | RVS-100 Vital Signs Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Rudolf Riester GmbH P.O.B. 35, Bruckstraße 31 Jungingen, DE 72417 |
| Contact | Christof Kleiner |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-23 |
| Decision Date | 2017-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396217348 | K170538 | 000 |
| 04045396216327 | K170538 | 000 |
| 04045396215863 | K170538 | 000 |
| 04045396214682 | K170538 | 000 |
| 04045396212718 | K170538 | 000 |
| 04045396000216 | K170538 | 000 |
| 04045396214699 | K170538 | 000 |