EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)


Device Classification Name

transmitters and receivers, electrocardiograph, telephone

510(k) Number K121628
Device Name EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
Applicant
EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD
1200 19th street, nw
washington, 
DC 
20032

Applicant Contact karl m nobert
Correspondent
EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD
1200 19th street, nw
washington, 
DC 
20032

Correspodent Contact karl m nobert
Regulation Number 870.2920
Classification Product Code
DXH  
Subsequent Product Codes
DPS   DSH  
Date Received 06/04/2012
Decision Date 06/25/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No