HANDHELD ECG MONITOR


Device Classification Name

electrocardiograph

510(k) Number K112622
Device Name HANDHELD ECG MONITOR
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Applicant Contact diana hong
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
p.o. box 237-023
shanghai, 

CN

200237

Correspodent Contact diana hong
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 09/08/2011
Decision Date 07/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No