HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES


Device Classification Name

electrode, cutaneous

510(k) Number K022917
Device Name HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
Original Applicant
HOME CARE TECHNOLOGY CO., LTD.
no. 58, fu-chiun st.
postal code 300
hsin-chu city, 

TW

300

Original Contact jen ke-min
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 09/03/2002
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No