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| Product | Model | Company | Device type |
|---|---|---|---|
| InnovianSW Assemby 7.1Draeger Medical Systems, Inc.Patient health record information system application software | MS24943 | Draeger Medical Systems, Inc. | Patient health record information system application software |
| Irregular Rhythm NotificationsApple Inc.Self-care monitoring/reporting software | Feature Version 1.x | Apple Inc. | Self-care monitoring/reporting software |
| Loss of Pulse DetectionFitbit LLCLoss-of-pulse emergency alert software | FB612 | Fitbit LLC | Loss-of-pulse emergency alert software |
| Miris Human Milk Analyzer™Miris ABBreast milk analyser IVD | Miris HMA US | Miris AB | Breast milk analyser IVD |
| myLUX™ Mobile DeviceBoston Scientific CorporationImplantable cardiac device management application software | 667259-100 | Boston Scientific Corporation | Implantable cardiac device management application software |
| Blood loss estimation application softwareStryker CorporationBlood loss estimation application software | 0894000004 | Stryker Corporation | Blood loss estimation application software |
| Neko HealthNeko Health ABPatient monitoring system module, multifunction | Echo-2 | Neko Health AB | Patient monitoring system module, multifunction |
| Platinum Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.Automatic-inflation electronic sphygmomanometer, portable, arm/wrist | BP5465 | Omron Healthcare, Inc. | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist |
| prolaio Personalized Physiology Analytics Engine Software (PPA)Prolaio, Inc.Electrocardiography monitoring system receiver | 1.0 | Prolaio, Inc. | Electrocardiography monitoring system receiver |
| Samsung Sleep Apnea Feature (Android OS)Samsung Electronics Co., Ltd.Patient general health self-management software | 1.X | Samsung Electronics Co., Ltd. | Patient general health self-management software |
| Samsung Sleep Apnea Feature (Wear OS)Samsung Electronics Co., Ltd.Patient general health self-management software | 1.X | Samsung Electronics Co., Ltd. | Patient general health self-management software |
| Sepsis ImmunoScorePrenosis, Inc.Clinical decision management support software IVD | 1.6.1 | Prenosis, Inc. | Clinical decision management support software IVD |
| Sleep Apnea Feature v2.0Samsung Electronics Co., Ltd.Patient general health self-management software | v2.X | Samsung Electronics Co., Ltd. | Patient general health self-management software |
| Sleep Apnea Notification Feature (SANF)Apple Inc.Self-care monitoring/reporting software | Feature version 1.X | Apple Inc. | Self-care monitoring/reporting software |
| SmartCardia 7L PlatformSmartCardia SAGeneral-purpose multi-parameter bedside monitor | 1007L | SmartCardia SA | General-purpose multi-parameter bedside monitor |
| SW ASCENT 2.4.0 DOWNLOADMedical Graphics CorporationPulmonary function analysis software, non-interpretive | 148025-502 | Medical Graphics Corporation | Pulmonary function analysis software, non-interpretive |
| T3 PLATFORM SOFTWAREEtiometry Inc.Clinical decision management support software | 2 | Etiometry Inc. | Clinical decision management support software |
| Triton Sponge System- NUI Sensor BracketStryker CorporationBlood loss estimation application software | PN 11028 | Stryker Corporation | Blood loss estimation application software |
| Vital SignsOxehealth LimitedNear-infrared camera vital sign measurement software | 2 | Oxehealth Limited | Near-infrared camera vital sign measurement software |
| Vital SyncCovidien LPMultiparameter physiologic analysis workstation | EWSSW01 | Covidien LP | Multiparameter physiologic analysis workstation |
| Vital-TracMindset Medical Inc.Camera application software | RROEMEMB | Mindset Medical Inc. | Camera application software |
| Vivio System AppVentric HealthCardiac mapping system application software | VA 1.0 | Ventric Health | Cardiac mapping system application software |
| Vivio System Arm CuffVentric HealthAutomatic-inflation electronic sphygmomanometer, portable, arm/wrist | VC 1.1 | Ventric Health | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist |
| Vivio System Arm CuffVentric HealthAutomatic-inflation electronic sphygmomanometer, portable, arm/wrist | 250028 | Ventric Health | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist |