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510(k) Data Aggregation
K Number
K082380Device Name
VICARDIO 12B
Manufacturer
Date Cleared
2008-12-03
(106 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
ENERGY-LAB TECHNOLOGIES GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The vicardio is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.
Device Description
The vicardio is a digital, PC-based electrocardiograph with a special isolation amplifier between the patient and the computer.
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