FDA 510(K) K110569, AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

Device Classification Name    Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number    K110569
Device Name    AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
Applicant    INOVISE MEDICAL, INC.
Regulation Number    870.2800
Classification Product Code    MLO  
Date Received    02/28/2011
Decision Date    10/24/2011
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Cardiovascular

Total pages: 303  
Fully redacted pages: 74  
Content pages: 229