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

Device Code: 891

Product Code(s): MWI

Device Classification Information

Device Type ID891
Device NameMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Regulation DescriptionCardiac Monitor (including Cardiotachometer And Rate Alarm).
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.2300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMWI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID891
DeviceMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Product CodeMWI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCardiac Monitor (including Cardiotachometer And Rate Alarm).
CFR Regulation Number870.2300 [🔎]
Premarket Reviews
ManufacturerDecision
AIRSTRIP TECH
 
SUBSTANTIALLY EQUIVALENT
2
AIRSTRIP TECHNOLOGIES
 
SUBSTANTIALLY EQUIVALENT
1
AIRSTRIP TECHNOLOGIES, LP
 
SUBSTANTIALLY EQUIVALENT
2
ALERTWATCH LLC
 
SUBSTANTIALLY EQUIVALENT
1
AMBIENT CLINICAL ANALYTICS
 
SUBSTANTIALLY EQUIVALENT
1
AXEO MEDICAL TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
1
CAPSULE TECHNOLOGIE
 
SUBSTANTIALLY EQUIVALENT
1
CAS MEDICAL SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN
 
SUBSTANTIALLY EQUIVALENT
2
DECISIO HEALTH, INC.
 
SUBSTANTIALLY EQUIVALENT
1
DICTUM HEALTH
 
SUBSTANTIALLY EQUIVALENT
1
EXCEL MEDICAL ELECTRONICS, LLC
 
SUBSTANTIALLY EQUIVALENT
1
FYSICON BV
 
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
3
GENERAL ELECTRIC CO.
 
SUBSTANTIALLY EQUIVALENT
3
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
4
HILL-ROM, INC.
 
SUBSTANTIALLY EQUIVALENT
2
INFINIUM MEDICAL
 
SUBSTANTIALLY EQUIVALENT
2
INNOKAS YHTYMA
 
SUBSTANTIALLY EQUIVALENT
1
INVIVO
 
SUBSTANTIALLY EQUIVALENT
1
IRADIMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
3
LD TECHNOLOGY LLC
 
SUBSTANTIALLY EQUIVALENT
1
MASIMO CORPORATION
 
SUBSTANTIALLY EQUIVALENT
6
MEDICAL INFORMATICS CORP
 
SUBSTANTIALLY EQUIVALENT
1
MIDMARK CORP.
 
SUBSTANTIALLY EQUIVALENT
1
MIDMARK CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
MINDRAY NORTH AMERICA
 
SUBSTANTIALLY EQUIVALENT
2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
 
SUBSTANTIALLY EQUIVALENT
1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
 
SUBSTANTIALLY EQUIVALENT
2
RUDOLF RIESTER GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
SKANRAY TECHNOLOGIES PVT LTD
 
SUBSTANTIALLY EQUIVALENT
1
SKANRAY TECHNOLOGIES PVT LTD
 
SUBSTANTIALLY EQUIVALENT
1
SOTERA WIRELESS, INC
 
SUBSTANTIALLY EQUIVALENT
1
SOTERA WIRELESS, INC.
 
SUBSTANTIALLY EQUIVALENT
2
TAIDOC TECHNOLOGY CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
TOSENSE, INC.
 
SUBSTANTIALLY EQUIVALENT
2
VIATOM TECHNOLOGY CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
1
VISIOMED TECHNOLOGY CO.,LTD
 
SUBSTANTIALLY EQUIVALENT
1
WELCH ALLYN, INC.
 
SUBSTANTIALLY EQUIVALENT
2
Device Problems
Incorrect Measurement
82
High Readings
29
Display Or Visual Feedback Problem
17
Inappropriate Or Unexpected Reset
9
Device Operates Differently Than Expected
7
Unable To Obtain Readings
7
Loose Or Intermittent Connection
4
Failure To Run On AC/DC
4
Sensing Intermittently
4
Device Stops Intermittently
4
Low Readings
3
Power Problem
2
Device Displays Incorrect Message
2
No Audible Alarm
2
No Display / Image
2
Image Reversal
2
Overheating Of Device
2
Incorrect, Inadequate Or Imprecise Result Or Readings
1
Calibration Problem
1
Low Audible Alarm
1
Complete Loss Of Power
1
Device Alarm System
1
Disconnection
1
Failure To Power Up
1
Inadequate Or Insufficient Training
1
Arcing
1
Image Display Error / Artifact
1
Failure To Calibrate
1
Therapeutic Or Diagnostic Output Failure
1
Connection Problem
1
Motherboard
1
Electrical /Electronic Property Problem
1
Device Difficult To Program Or Calibrate
1
Decoupling
1
Battery Problem
1
Improper Or Incorrect Procedure Or Method
1
Device Operational Issue
1
Total Device Problems 202
Recalls
Manufacturer Recall Class Date Posted
1
INNOKAS MEDICAL OY
II Aug-19-2016
2
INNOKAS MEDICAL OY
II Jan-28-2015
3
Innokas Medical Oy
II Nov-11-2015
4
Invivo Corporation
II Sep-18-2018
5
Invivo Corporation
II Jun-07-2018
6
Invivo Corporation
II May-14-2018
7
Invivo Corporation
II Dec-19-2017
8
Invivo Corporation
II Nov-09-2017
9
Invivo Corporation
II Sep-21-2016
10
Invivo Corporation
II Sep-08-2016
11
Invivo Corporation
II Jan-13-2015
12
Invivo Corporation
II Oct-15-2014
13
Invivo Corporation
II Oct-01-2014
14
Invivo Corporation
II Aug-19-2014
15
Invivo Corporation
II Feb-26-2014
16
Invivo Corporation
II Feb-14-2014
17
Mckesson Information Solutions LLC
II Oct-20-2014
18
Mckesson Information Solutions LLC
II Oct-08-2014
19
Medrad Mr Inc
II Jan-23-2014
20
Nellcor Puritan Bennett Inc. (dba Covidien LP)
II Aug-14-2014
21
Philips Electronics North America Corporation
II Jul-27-2015
22
Welch Allyn Protocol, Inc
II Jan-07-2014
TPLC Last Update: 2019-04-02 19:44:28

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