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510(k) Data Aggregation
K Number
K092324Device Name
SPIROPRO
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2009-09-03
(30 days)
Product Code
DQA, BTY
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.
Device Description
SpiroPro® is a recording and diagnostic system for measurement, recording and assessment of the Flow-Volume curve and Flow-Volume parameters. The analyzed data can be immediately printed out or saved to the internal memory.
The portable spirometer is small, easy to handle and allows determination of inspiratory and expiratory lung volumes (VCin, FVC, FEV1, MEF50, ... ) including pre and post measurement with date and time display. An interpretation program automatically assesses the measured data. Optionally, the measurement of the oxygen saturation of the blood (SpO2) and the pulse rate are available and a 6-minute walk test can be performed. The graphic LCD and the menu-guided graphical user interface comply with the latest technological developments. Just touch the appropriate icon with your finger to enter patient data or to select menu items (touch screen). Selfexplanatory icons and the logical menu structure safely guide you through the procedure Storage capacity is high: up to 550 measurements can be saved in the internal database.
The rechargeable lithium-ion battery allows operation of the SpiroPro® for approximately two weeks. A charging unit, able to charge the battery within two hours, is included in the delivery.
Patient data, recording results and graphs can be directly printed out on a PCL-compatible printer (for example HP DeskJet series). Of course, data transfer to a PC and vice versa is possible via the serial interface and the Bluetooth interface. The optional software package "SpiroPro® for Windows®" allows automatic transfer of data which are then saved on the PC. The easy-to-exchange, high-quality pneumotach guarantees a high degree of patient safety and provides precise recording results.
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K Number
K091412Device Name
CLEAN PEAK FLOW METER
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2009-08-21
(100 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population:
Children scale / 50 – 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
Adult scale / 50 - 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use: Places where a patient may require the measurement of their peak expriatory flow rate.
Device Description
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
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K Number
K091505Device Name
COR12+
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2009-06-10
(20 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Cor12+ acquires, digitizes and stores data to be analyzed on a computer with special software.
The Cor12+ is indicated for use:
in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours.
The Cor12+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.
Device Description
The digital Holter ECG recorder Cor12+ is a portable battery operated ECG amplifier with build in data storage on memory card (Mini SD size):
- Single dual color (green/yellow) LED .
- Button control (one Button) to activate communication interface, event . recording
- Two standard size AA batteries .
- Speaker for voice output for alarm messages .
- PC program to set-up recorder via blue-tooth communication interface 0
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K Number
K081823Device Name
MASTERSCREEN PAED - BABY BODY
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2009-05-18
(325 days)
Product Code
CCM, BZC
Regulation Number
868.1750Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.
The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.
Device Description
MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics:
- Mains operation .
- Trolley for device and Baby Body box .
- Personal Computer System .
- Graphic user interface Windows XP Professional .
- Powerful database for storing patient- and test data .
- Tidal Breathing Analysis .
- Baby-Body Plethysmography .
- Baby Resistance / Compliance .
- Rapid Thoracic Compression (RTC) .
- Raised Volume Rapid Thoracic Compression (RV-RTC) .
- Spirometry / Flow Volume / MVV for children and adolescents ◆
- Airway Resistance (R Occlusion) for children and adolescents .
- P.01 / PImax / PEmax for children and adolescents .
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K Number
K080510Device Name
VIP PULMONARY FUNCTION SYSTEM
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2008-08-20
(177 days)
Product Code
BTY
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below.
· Differential diagnosis (heart/lungs)
· Disability assessment
• Rehabilitation evaluation
- · Exercise prescription
- · Sports medicine/research
- · Energy assessment, substrate utilization
- · Assessment of supplemental O2 requirement
- · Evaluation of medication effects
- · Pulmonary Function testing for adults and children
- · Document effectiveness of bronchodilator therapy
- Pulmonary disability evaluation
- · Industrial surveillance · Bronchial challenge testing
- · Exercise induced bronchial spasm
- · Pre-surgical risk evaluation
- Bedside lung function
Device Description
Not Found
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K Number
K080734Device Name
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2008-06-26
(104 days)
Product Code
BTY, DPS
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Federal U.S. law restricts this device to sale by or on the order of a physician.
Device Description
FlowScreen is an active medical device providing following characteristics:
Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card
a) pulmonary functions
Measurement with ultrasonic handle or pneumotach handle .
Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... )
Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
Flow-Volume and Volume-Time Loop, pre/post tests .
MVV measurement
Trending capabilities
Patient Incentive animations
Interpretation modules .
b) ECG functions
. Simultaneous acquisition of the 12 standard leads
Storage of 10 seconds of acquired ECG signal .
Digital filters for base-line drift and mains interference suppression
Interpretation program Hanover ECG System (HES) providing the following . additional information:
Representatives templates of each lead including markers on fiducial O points
Summary of mean measurements O
Rhythm Analysis statements O
Signal noise detection and information O
Specific findings on QRS complex
Conduction statements O
QRS T diagnostic statements O
Arrhythmia monitoring detection o
Heart Rate Variability 0
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K Number
K072061Device Name
MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2008-04-22
(270 days)
Product Code
JEH
Regulation Number
868.1760Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.
MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).
MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.
Device Description
Not Found
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K Number
K072323Device Name
MASTERSCREEN & OXYCON CPX
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2007-10-10
(51 days)
Product Code
BZC
Regulation Number
868.1880Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viasys MASTERSCREEN CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The MASTERSCREEN CPX system allows the monitoring of metabolic parameters. The MASTERSCREEN CPX system is intended to use with adults and children over the age of 14 years.
Device Description
Not Found
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K Number
K071753Device Name
MASTERSCREEN PNEUMO & MASTERSCOPE
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2007-08-14
(47 days)
Product Code
BTY
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Masterscreen Pneumo / Masterscope is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flowvolume measurements. Mostly it will be used for COPD and Asthma patients.
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
The Masterscreen Pneumo / Masterscope is powered from 100-240V / 50-60Hz wall outlets. No energy is transferred to the patient.
Device Description
Not Found
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K Number
K062011Device Name
MODIFICATION TO FLOWSCREEN
Manufacturer
VIASYS HEALTHCARE GMBH
Date Cleared
2007-05-11
(298 days)
Product Code
BTY
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
VIASYS HEALTHCARE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
Device Description
Not Found
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