Product code MWI
- Device name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2300
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor H... | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2024-03-08 |
| K231086 | CPM System | Analog Devices, Inc. | 2023-12-22 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023-10-30 |
| K230881 | Change Healthcare Cardiology Hemodynamics™ | Change Healthcare Israel , Ltd. | 2023-09-11 |
| K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait S... | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 |
| K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023-06-06 |
| K230214 | Huma RPM (RPM) | Medopad, Inc. | 2023-06-02 |
| K222330 | The Heart Seat | Casana Care, Inc. | 2023-04-24 |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | 2023-03-06 |
| K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 |
| K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 |
| K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022-10-28 |
| K212975 | MedWand | Medwand Solutions, Inc. | 2022-07-22 |
| K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022-01-14 |
| K211754 | Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. | 2021-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3944670047010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700068020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700064010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700063010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700051020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048100 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048090 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048080 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048070 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048060 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048050 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048030 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3944060056010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945000030010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300046010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945600013020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048040 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| 08719689142124 | QMAPP | Fysicon B.V. | 2026-05-19 |
| 08719689142131 | QMAPP | Fysicon B.V. | 2026-05-19 |
| EMIP50100491 | SpO2 Finger Adapter M-Flex | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022-11-24 |
| EMIP50101031 | SpO2 Clip Adapter | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022-11-24 |
| G012BRCA02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| 07613365000467 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000474 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000481 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000498 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |