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510(k) Data Aggregation
K Number
K121825Device Name
CS-MAG II
Manufacturer
Date Cleared
2013-03-11
(263 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
BIOMAGNETIK-PARK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BMP MCG CS-MAG II Magnetocardiograph is intended for use as tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
Device Description
The BMP MCG CS-MAG II system will be used for diagnostic purposes in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, multichannel body surface mapping technique to record biomagnetic signals from the heart generated by the same ionic currents underling the electrocardiogram. Compared to electrocardiography (ECG), MCG has similar morphological features such as T-, P-, and Q-waves, and the QRS complex. The advantages of MCGs over traditional ECGs are increased sensitivity to weak signals, lack of distortion from conductivity in body tissues, and presentation of direct current (DC) component signals and primary currents.
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