ACG-8511 PORTABLE ECG MONITOR


Device Classification Name

electrocardiograph

510(k) Number K110328
Device Name ACG-8511 PORTABLE ECG MONITOR
Applicant
ANDON HEALTH CO.,LTD
no 3, jinping street ya an rd
nankai district
tianjin, 

CN

300190

Applicant Contact liu yi
Correspondent
ANDON HEALTH CO.,LTD
no 3, jinping street ya an rd
nankai district
tianjin, 

CN

300190

Correspodent Contact liu yi
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 02/03/2011
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No