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Cardiovascular QDA 04/03/2025 K243305 Masimo W1 Masimo Corporation Cardiovascular DPS 03/21/2025 K243185 REMI Remote EEG Monitoring System Epitel Neurology OMC 03/21/2025 K250106 Signos Glucose Monitoring System Signos, Inc. Clinical Chemistry SAF 03/19/2025 K243092 AcuPebble Ox (200) Acurable Limited Anesthesiology MNR 03/14/2025 K241960 DeepRESP Nox Medical ehf Neurology OLZ 03/07/2025 K243515 EpiWatch Monitoring System EpiWatch, Inc. Neurology POS 02/28/2025 K242876 Pulse Oximeter ( PO2, PO2A, PO2B) Shenzhen Viatom Technology Co., Ltd. Cardiovascular DQA 02/25/2025 K233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) Taiwan Aulisa Medical Devices Technologies, Inc. Cardiovascular DQA 02/25/2025 K242967 Loss of Pulse Detection Fitbit Cardiovascular SDY 02/20/2025 K242447 Falcon HST Compumedics Limited Neurology OLV 02/13/2025 K243778 Body Temperature Software (BTS) Fitbit, LLC General Hospital QZA 02/03/2025 K243268 TipTraQ (TTQ001) PranaQ Pte. Ltd. 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Clinical Chemistry QBJ 02/15/2024 K232915 EpiMonitor Empatica Srl Neurology POS 02/06/2024 DEN230041 Sleep Apnea Feature Samsung Electronics Co., Ltd Anesthesiology QZW 02/04/2024 K232210 X-trodes System M X-Trodes Neurology GWL 12/21/2023 K231531 Pediarity™ Gabi SmartCare SA Cardiovascular DQA 12/15/2023 DEN230050 Body Temperature Software (BTS) Fitbit, LLC General Hospital QZA 12/15/2023 K223721 Masimo Stork Masimo Corporation Cardiovascular DQA 12/08/2023 K232053 SimpleSense-BP, SimpleSense-BP Software Application Nanowear Inc. Cardiovascular DXN 11/30/2023 K231546 Somfit Compumedics Limited Anesthesiology MNR 11/17/2023 K232512 Masimo W1 Masimo Corporation Cardiovascular DPS 11/08/2023 DEN220091 Dream Sock Owlet Baby Care, Inc. Cardiovascular QYU 10/30/2023 K230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Empatica S.r.l. 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Cardiovascular DXH 04/08/2022 K212372 Fitbit Irregular Rhythm Notifications Fitbit Inc Cardiovascular QDB 03/24/2022 K211365 Alio Medical Remote Monitoring System Graftworx, Inc. dba Alio Cardiovascular DRG 03/11/2022 K211887 Personal Kinetigraph (PKG) System Gen 2 Plus GKC Manufacturing Pty Ltd Neurology GYD 02/24/2022 K220028 NightOwl Ectosense nv Anesthesiology MNR 01/07/2022 DEN210015 Sunrise Sleep Disorder Diagnostic Aid Sunrise Ear Nose & Throat QRS 12/21/2021 K203343 Wesper Lab Wesper Inc. Anesthesiology MNR 12/16/2021 K213463 NightOwl Ectosense NV Anesthesiology MNR 11/30/2021 K211668 KardiaMobile Card AliveCor, Inc. Cardiovascular DXH 11/22/2021 K210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care Inc. Clinical Chemistry QLG 10/22/2021 K212516 IRNF App Apple Inc. 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Clinical Chemistry QBJ 07/06/2021 K210480 AcuPebble SA Acurable Limited Anesthesiology MNR 06/30/2021 K210753 KardiaMobile 6L AliveCor, Inc. Cardiovascular DXH 06/16/2021 K210034 EnsoSleep EnsoData, Inc. Neurology OLZ 06/07/2021 K201914 HRVWatch-Mini Wrist Monitor Taiwan Scientific Corporation Cardiovascular DXN 05/21/2021 K202359 Zio Monitor iRhythm Technologies, Inc. Cardiovascular DSH 05/21/2021 K202527 Zio ECG Utilization Software (ZEUS) System iRhythm Technologies, Inc. Cardiovascular DQK 05/07/2021 K202145 Bigfoot Unity Diabetes Management System Bigfoot Biomedical, Inc. Clinical Chemistry QLG 04/01/2021 K202228 Omron Model BP7900 Blood Pressure Monitor + EKG Omron Healthcare, Inc. Cardiovascular DXN 02/06/2021 K200276 SPEAC System Brain Sentinel, Inc. Neurology POS 01/27/2021 K193386 Wrist Electronic Sphygmomanometer Shenzhen Changkun Technology Co., Ltd. Cardiovascular DXN 01/25/2021 K201468 Pulse Oximeter Shenzhen Creative Industry Co., Ltd. Cardiovascular DQA 12/04/2020 K200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom, Inc. Clinical Chemistry QBJ 12/03/2020 K201977 TempTraq Blue Spark Technologies, Inc. General Hospital FLL 11/06/2020 K201669 SimpleSENSE Nanowear Inc. Cardiovascular DXH 10/30/2020 K193296 eCordum Cardiac Monitor (eCordum CM) Ecordum, Inc. Cardiovascular DXH 10/08/2020 K201525 ECG App Apple Inc. Cardiovascular QDA 09/25/2020 K201439 Ventilator, Non-continuous (Respirator) Respironics, Inc. Anesthesiology BZD 09/11/2020 K200948 Fitbit ECG App Fitbit, Inc. Cardiovascular QDA 08/04/2020 K201168 ECG Monitor App Samsung Electronics Co., Ltd Cardiovascular QDA 07/12/2020 K193628 AGE Automatic Wrist Blood Pressure Monitor Dongguan E-Test Technology Co., Ltd Cardiovascular DXN 06/12/2020 K193371 FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care Inc. Clinical Chemistry QLG 06/01/2020 K191620 Vitls Platform Vitls Inc. 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