ClearanceBrief
Panels › Cardiovascular › Product code MWI · Class 2

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Regulation 870.2300

6510(k)s in 12 months (309 all time)
11recalls in 12 months (85 all time)
80recalls that name a 510(k)
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Top companies in MWI

DateFirm and productCodeLinked 510(k)
Oct 15, 2014Invivo Corporation
Philips Expression MR200 MRI Patient Monitoring System
Terminated
MWIK131382
Oct 8, 2014Mckesson Information Solutions LLC
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Terminated
MWIK131497
Oct 1, 2014Invivo Corporation
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Terminated
MWIK131382
Sep 14, 2014Invivo Corporation
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200
Terminated
MWIK121424
Aug 19, 2014Invivo Corporation
Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care pr
Terminated
MWIK121424
Aug 14, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtua
Terminated
MWIK130796
K132604 +1
Aug 14, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Pat
Terminated
MWIK130796
K132604 +1
Feb 26, 2014Invivo Corporation
Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is int
Terminated
MWIK121424
Feb 14, 2014Invivo Corporation
Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI proced
Terminated
MWIK121424
Jan 23, 2014Medrad Mr Inc
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made ava
Terminated
MWIK042569
Jan 7, 2014Welch Allyn Protocol, Inc
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for
Terminated
MWIK033378
Jul 29, 2013Sotera Wireless, Inc.
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parame
Terminated
MWIK112478
K122036
Jul 29, 2013Sotera Wireless, Inc.
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of
Terminated
MWIK112478
K122036
Jun 25, 2013Medrad Inc
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Terminated
MWIK042569
Feb 14, 2013Viterion TeleHealthcare Llc
Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V5
Terminated
MWIK004050
Feb 14, 2013Viterion TeleHealthcare Llc
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth
Terminated
MWIK030419
Feb 14, 2013Viterion TeleHealthcare Llc
Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500
Terminated
MWIK030419
Jan 27, 2013Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Terminated
MWIK053234
Dec 4, 2012Invivo Corporation
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoin
Terminated
MWIK090785
Sep 13, 2012Capsule Tech Inc.
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. T
Terminated
MWIK013019
K020197 +2
Feb 15, 2012Viterion TeleHealthcare Llc
Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer H
Terminated
MWINone listed
Oct 27, 2011Invivo Corporation
Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***In
Terminated
MWIK053462
Oct 25, 2011Invivo Corporation
"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564
Terminated
MWIK090785
Jun 1, 2011Capsule Tech Inc.
Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. Catalog Number: DC-NU-MPC Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data th
Terminated
MWIK013019
K020197 +1
May 11, 2011Remote Diagnostic Technologies Ltd.
TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG mo
Terminated
MWIK101264
Apr 8, 2010Philips Healthcare Inc.
DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices including urimeters, ventilators, oximeters, patient monitors, infusion pumps and anesthesia machines.
Terminated
MWIK051134
Jul 30, 2009Welch Allyn Protocol, Inc
Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units co
Terminated
MWIK053027
K063419
Feb 6, 2009Invivo Corporation
3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 These rechargeab
Terminated
MWIK053462
K063559
Jul 23, 2007Smiths Medical PM, Inc.
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
Terminated
MWIK010770
K030407 +1
Dec 15, 2006Medrad Inc
Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological monitor.
Terminated
MWIK042569
Dec 15, 2006Medrad Inc
Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Bloo
Terminated
MWIK983250
Nov 28, 2006Welch Allyn Protocol, Inc
Propaq LT vital signs monitor, Model 802LTRN
Terminated
MWIK033378
Nov 28, 2006Welch Allyn Protocol, Inc
Propaq LT vital signs monitor, Model 802LTON
Terminated
MWIK033378
Dec 23, 2005Witt Biomedical Corporation
Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
Terminated
MWIK033030
Oct 15, 2003GE Medical Systems Information Technologies
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Me
Terminated
MWIK012915
K020022 +1

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