HANDHELD ECG MONITOR, MODEL MD100


Device Classification Name

electrocardiograph

510(k) Number K080933
Device Name HANDHELD ECG MONITOR, MODEL MD100
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
suite 8d zhongxin zhongshan
mansion, no. 19, lane 999
shanghai, 

CN

20020

Applicant Contact diana hong
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
suite 8d zhongxin zhongshan
mansion, no. 19, lane 999
shanghai, 

CN

20020

Correspodent Contact diana hong
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 04/02/2008
Decision Date 09/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No