510(k) K170538
- Device
- RVS-100 Vital Signs Monitor
- Applicant
- Rudolf Riester GmbH
- 510(k) number
- K170538
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-17
- Date received
- 2017-02-23
- Regulation
- 870.2300
- Classification name
- Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Christof Kleiner
- Address
- P.O.B. 35, Bruckstraße 31 Jungingen DE 72417 72417
FDA Registration Numbers#
- 3021632375
- 3004188066
- 3012528160
- 3009831876
- 3000126629
- 3035111606
- 9610816
- 3007836437
- 3014886121
- 3013501110
- 3006546174
- 1000122786
- 3043543260
- 8020045
- 3011683100
- 9616760
- 9681548
- 1066270
- 3003591740
- 3010120148
- 2027454
- 3018514222
- 3021343210
- 3003294644
- 3003681187
- 3002736372
- 3000976525
- 3006104191
- 3007029079
- 3011200896
- 3013298431
- 1058584
- 8022257
- 1221108
- 3010824458
- 9615102
- 3007413079
- 3016674095
- 3022425463
- 3012238587
- 3023412068
- 3005521864
- 1064859
- 3008255748
- 3007305624
- 3038259592
- 9610105
- 3027256461
- 3009673645
- 3010863450
- 9710602
- 3008365372
- 3013896610
- 3009001657
- 3004415095
- 3033715634
- 3006648320
- 3010041430
- 2183613
- 2936999
- 3016852448
- 1930027
- 3003589956
- 3007481893
- 2952596
- 3006808382
- 3019834104
- 3010692333
- 3006979678
- 3010097171
- 3008716327
- 3010032903
- 3012933969
- 1316463
- 3009077524
- 3013596024
- 3016670256
- 3029871637
- 3006733253
- 3009156722
Source Documents#
Other 510(k) Records For Product Code MWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | 2026-08-14 |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026-08-12 |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026-06-12 |
| K253436 | c-med0 alpha | Cosinuss GmbH | 2026-04-30 |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025-08-27 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025-06-06 |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025-02-14 |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024-12-20 |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | 2024-12-10 |
| K233446 | AMC Health CareConsole | Amc Health | 2024-09-27 |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024-09-24 |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024-06-26 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 |
Legacy Summary#
summary
FDA Review#
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