RVS-100 Vital Signs Monitor
FDA 510(k) K170538 · Rudolf Riester GmbH
510(k) numberK170538
Submission
- Device name
- RVS-100 Vital Signs Monitor
- Applicant
- Rudolf Riester GmbH
Jungingen, DE - Received
- February 23, 2017
- Decision date
- October 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
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| K972379 | Precisa NDXQ · Traditional | 09/24/1997SE |
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| K972301 | Big Ben Square, Big Ben RoundDXQ · Traditional | 09/17/1997SE |
| K964338 | Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-SpotHKM · Traditional | 01/09/1997SE |
| K950914 | Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic…HLJ · Traditional | 07/24/1995SE |
Questions and answers
When was RVS-100 Vital Signs Monitor cleared by the FDA?
RVS-100 Vital Signs Monitor (K170538) received a 510(k) decision of Substantially Equivalent on October 17, 2017, 236 days after the submission was received.
What is the product code of K170538?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.