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510(k) Data Aggregation
K Number
K023015Device Name
CARDIS
Manufacturer
Date Cleared
2002-09-25
(15 days)
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
SCHWARZER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.
The Schwarzer cardis systems are intended for use in catheterization labs.
The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.
Device Description
The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.
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