FDA 510(k), K140497, ECVUE MAPPING SYSTEM
FDA 510(k), K140497, ECVUE MAPPING SYSTEM
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510(K) Number: K140497
Device Name: ECVUE MAPPING SYSTEM
Manufacturer: CARDIOINSIGHT TECHNOLOGIES, INC
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 02/27/2014
Decision Date: 11/19/2014
Regulation Medical Specialty: Cardiovascular
Device Name: ECVUE MAPPING SYSTEM
Manufacturer: CARDIOINSIGHT TECHNOLOGIES, INC
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 02/27/2014
Decision Date: 11/19/2014
Regulation Medical Specialty: Cardiovascular