510(k) K210086
- Device
- Vitals360 Multi-Vitals Mobile Monitor
- Applicant
- VoCare, Inc.
- 510(k) number
- K210086
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-20
- Date received
- 2021-01-13
- 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
- Steve Peabody
- Address
- 4950 Turkey Foot Rd. Zionsville IN US 46077 46077
FDA Registration Numbers#
- 1833920
- 3003174284
- 3010390468
- 9710602
- 3004188066
- 2952596
- 3004091281
- 3007134734
- 3013298431
- 3011651230
- 3008716327
- 3008787503
- 3010692333
- 3004906872
- 3005053560
- 8020045
- 3008729547
- 3003591740
- 3000976525
- 1527715
- 3033715634
- 2032233
- 1221108
- 3016852448
- 1930027
- 9680215
- 1066427
- 3011683100
- 3018514222
- 3029871637
- 1066270
- 3004145393
- 8040564
- 3005803793
- 3008164770
- 1220908
- 3013896610
- 9616760
- 3019834104
- 3011200896
- 8021084
- 3016674095
- 3035111606
- 9681548
- 3003589956
- 3005569927
- 3021343210
- 3008977358
- 8010482
- 3043543260
- 3012251275
- 2221819
- 9610816
- 8030229
- 2011171
- 3003768277
- 3012528160
- 3012933969
- 1051786
- 3007481893
- 1062836
- 3019388613
- 3007029079
- 3037341611
- 3023412068
- 3015142815
- 1064859
- 1222630
- 3036798186
- 3006104191
- 3000130829
- 3012103976
- 3009077524
- 3004415095
- 3022425463
- 3015529350
- 3011359729
- 8043459
- 3012359877
Source Documents#
Other 510(k) Records For Product Code MWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases