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510(k) Data Aggregation
K Number
K973735Device Name
MICROVIT MT-100
Manufacturer
SCHILLER AMERICA, INC.
Date Cleared
1998-08-25
(329 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
SCHILLER AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.
Device Description
The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardlographs for 24 hours, on two channels.
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K Number
K973751Device Name
MT-200
Manufacturer
SCHILLER AMERICA, INC.
Date Cleared
1998-08-25
(328 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
SCHILLER AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.
Device Description
The ECG Holter evoluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter EOG recordings. The Holter iscoralings are used for the diagnostics of symptomatic and asymptomatic arrhythings, i.e. bradyeardia, tachycardia, diagnastic of arthythinias in pattents with coraniary artery disease, in cardiomopathy, high blood pressure, long QT syndrome, A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics. The software runs on Windows™ 95.
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K Number
K970879Device Name
CARDIOVIT CS-200
Manufacturer
SCHILLER AMERICA, INC.
Date Cleared
1997-06-25
(107 days)
Product Code
LOS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SCHILLER AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.
Device Description
Not Found
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