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FDA 510(k), K130626, MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
FDA 510(k), K130626, MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
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510(K) Number: K130626
Device Name: MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
Manufacturer: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 03/08/2013
Decision Date: 05/01/2013
Regulation Medical Specialty: Cardiovascular
Device Name: MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
Manufacturer: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 03/08/2013
Decision Date: 05/01/2013
Regulation Medical Specialty: Cardiovascular
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