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.
8770 sw nimbus avenue
suite d
beaverton, 
OR 
97008 -7196

Applicant Contact earl anderson
Correspondent
INOVISE MEDICAL, INC.
8770 sw nimbus avenue
suite d
beaverton, 
OR 
97008 -7196

Correspodent Contact earl anderson
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

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No