ECG SERIES ELECTROCARDIOGRAPH


Device Classification Name

electrocardiograph

510(k) Number K111805
Device Name ECG SERIES ELECTROCARDIOGRAPH
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 w 20 st
hialeah, 
FL 
33010

Applicant Contact jorge millan
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 w 20 st
hialeah, 
FL 
33010

Correspodent Contact jorge millan
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 06/27/2011
Decision Date 08/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No