Product Code: MWI


Products Classified as MWI

891Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)Cardiac Monitor (including Cardiotachometer And Rate Alarm).

Total Product Life Cycle (TPLC) Devices

891Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)Cardiac Monitor (including Cardiotachometer And Rate Alarm).

FDA Consensus Standards

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) [33227]21 CFR §870.2300 🔎
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) [37694]21 CFR §870.2300 🔎
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) [38117]21 CFR §870.2300 🔎
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) [31353]21 CFR §870.2300 🔎

Pre-market Notifications for MWI

K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., LTD
K213335Capsule Surveillance SystemCapsule Surveillance Technologies, SAS /Capsule Tech, Inc.
K212975MedWandMedWand Solutions, Inc.
K212473Welch Allyn Connex Central StationWelch Allyn, Inc.
K212227Philips MR Patient Care PortalInvivo Corporation
K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie SAS
K210086Vitals360 Multi-Vitals Mobile MonitorVoCare, Inc.
K202892Vital Signs Monitor:iM3s, IM3As, IM3Bs, IHM3sEdan Instruments, Inc.
K202306T3 Platform SoftwareEtiometry, Inc.
K201635MouthLab Vital Signs Monitoring SystemMultiSensor Diagnostics (dba Aidar Health)
K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie SAS
K200717CLEWICU System (ClewICUServer And ClewICUnitor)CLEW Medical Ltd.
K193242Masimo Rad-97 Pulse CO-Oximeter And Accessories, Masimo Radical-7 Pulse CO-Oximeter And Accessories, Masimo Radius-7 Pulse CO-Oximeter And AccessoriesMasimo Corporation
K192004Eko Analysis SoftwareEko Devices Inc
K191989WVSM (Wireless Vital Signs Monitor) RWC + MiniCapAthena GTX

Global Unique Device Identification Database

00616258009643Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009636Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009629Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009612Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009605Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009599Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009582Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009575Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009568Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
00616258009551Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
10616258009541Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
10616258009534Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
10616258009527Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
10616258009510Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
10616258009503Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Maude Adverse Events

RD SEDLINE SENSORMASIMO - 52 DISCOVERY2020-03-20
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-03-19
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-03-19
Xper Flex Cardio Physiomonitoring SystemINVIVO CORPORATION2020-03-19
Xper Flex Cardio Physiomonitoring SystemINVIVO CORPORATION2020-03-19
RAD-97 W/NIBPMASIMO - 52 DISCOVERY2020-03-17
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-03-17
RD SEDLINE SENSORMASIMO - 52 DISCOVERY2020-03-14
ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATUMASIMO - 52 DISCOVERY2020-03-14
RD SEDLINE SENSORMASIMO - 52 DISCOVERY2020-03-14
PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEMINVIVO CORPORATION2020-03-13
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-03-13
PHILIPS EXPRESSION MR200INVIVO CORPORATION2020-03-04
SEDLINE MODULE ONLYMASIMO - 52 DISCOVERY2020-03-02
ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATUMASIMO - 52 DISCOVERY2020-02-26
PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEMINVIVO CORPORATION2020-02-24
RAD-97 W/NIBPMASIMO - 52 DISCOVERY2020-02-21
PHILIPS EXPRESSION INFORMATION PORTAL (IP5)INVIVO CORPORATION2020-02-21
SEDLINE KITMASIMO - 52 DISCOVERY2020-02-14
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-02-13
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-02-13
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-02-12
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2020-02-12
ROOTMASIMO CORPORATION2020-01-31
RAD-97 W/CAPNOGRAPHYMASIMO - 52 DISCOVERY2020-01-30
SEDLINE KITMASIMO - 52 DISCOVERY2020-01-27
ROOTMASIMO - 52 DISCOVERY2020-01-24
EXPRESSIONINVIVO CORPORATION2020-01-17
PHILIPS HEALTHCARE MONITORPHILIPS HEALTHCARE / PHILIPS MEDIZIN SYSTEMS BOEBLINGEN GMBH2020-01-14
DASH 3000 PATIENT MONITORGE HEALTHCARE2020-01-13
RAD-97 W/NIBPMASIMO - 52 DISCOVERY2019-11-20
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2019-11-19
ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATUMASIMO - 52 DISCOVERY2019-11-15
KIT, RAD-97 PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2019-11-01
ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATUMASIMO - 52 DISCOVERY2019-10-25
KIT, RAD-97 PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2019-10-18
ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATUMASIMO - 52 DISCOVERY2019-10-18
KIT, RAD-97 PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2019-10-17
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2019-10-11
ROOTMASIMO CORPORATION2019-10-11
KIT, RAD-97 PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2019-10-10
KIT, RAD-97 PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2019-10-10
PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEMINVIVO CORPORATION2019-10-02
Xper Flex Cardio Physiomonitoring SystemINVIVO CORPORATION2019-10-02
SEDLINE KITMASIMO - 52 DISCOVERY2019-09-27
RAD-97 W/NIBPMASIMO - 52 DISCOVERY2019-09-27
KIT, RAD-97 PULSE CO-OXIMETERMASIMO - 52 DISCOVERY2019-09-16
CARDIOVASCULAR MONITORINVIVO CORPORATION2019-09-16
CONNECXWELCH ALLYN, INC.2019-09-11
XPER FLEX CARDIO PHYSIOMONITORING SYSTEMINVIVO CORPORATION2019-09-10
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.