ECG-6 SERIES ELECTROCARDIOGRAPH


Device Classification Name

electrocardiograph

510(k) Number K112135
Device Name ECG-6 SERIES ELECTROCARDIOGRAPH
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 west 20 st
hialeah, 
FL 
33010

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

Correspodent Contact jorge millan
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 07/26/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No