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 |
|---|---|---|---|
| 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 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04255629200973 | NIBP Pressure cuff 14 - 21,5 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2026-06-24 |
| 04255629200980 | NIBP Pressure cuff 20,5 - 28,5 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2026-06-24 |
| 04255629200997 | NIBP Pressure cuff 27 - 35 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2026-06-24 |
| 04255629201000 | NIBP Pressure cuff 34 - 44 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2026-06-24 |
| 04255629201017 | Gas Sample Line Set | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2026-06-24 |
| 04255629200966 | NIBP Pressure cuff 9 - 15 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2026-06-24 |
| B153301020 | AirStrip ONE Client Android | Airstrip Technologies, Inc. | 2026-03-18 |
| B153301010 | AirStrip ONE Client iOS | Airstrip Technologies, Inc. | 2026-03-18 |
| B153300010 | AirStrip ONE Platform | Airstrip Technologies, Inc. | 2026-03-18 |
| 10884838117874 | MR Patient Care Pediatric SpO2 Clip | Philips Medizin Systeme Böblingen GmbH | 2025-05-22 |
| 10884838117867 | MR Patient Care Adult SpO2 Clip | Philips Medizin Systeme Böblingen GmbH | 2025-05-19 |
| 00616784084015 | Vital Signs Patient Monitor | Dynarex Corporation | 2020-02-01 |
| 00616784084114 | Vital Signs Patient Monitor | Dynarex Corporation | 2020-02-01 |
| EMIP54000171 | Gas Sample Line Set | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2019-11-11 |
| EMIP51000420 | NIBP Pressure cuff 34 - 44 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2019-11-11 |
| EMIP51000410 | NIBP Pressure cuff 27 - 35 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2019-11-11 |
| EMIP51000400 | NIBP Pressure cuff 20,5 - 28,5 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2019-11-11 |
| EMIP51000390 | NIBP Pressure cuff 14 - 21,5 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2019-11-11 |
| EMIP51000380 | NIBP Pressure cuff 9 - 15 cm | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2019-11-11 |
| 00732094209167 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209334 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209372 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209518 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209570 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209679 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209792 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209860 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209921 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094209983 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |
| 00732094210002 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2017-12-05 |