FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE


Device Classification Name

electrode, cutaneous

510(k) Number K110289
Device Name FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
Applicant
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
no 9, gao zin 1st road
hi-tech development zone
xi’an, shaanxi, 

CN

710075

Applicant Contact zhai ying chuan
Correspondent
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
no 9, gao zin 1st road
hi-tech development zone
xi’an, shaanxi, 

CN

710075

Correspodent Contact zhai ying chuan
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 02/01/2011
Decision Date 08/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No