HIVOX BIOTEK INC.


Device Classification Name

stimulator, nerve, transcutaneous, over-the-counter

510(k) Number K112392
Device Name HIVOX BIOTEK INC.
Applicant
HIVOX BIOTEK, INC.
no. 58, fu-chiun st.
hsin-chu city, 

TW

30067

Applicant Contact jen ke-min
Correspondent
HIVOX BIOTEK, INC.
no. 58, fu-chiun st.
hsin-chu city, 

TW

30067

Correspodent Contact jen ke-min
Regulation Number 882.5890
Classification Product Code
NUH  
Date Received 08/18/2011
Decision Date 03/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No