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
|
|
Correspondent Contact |
JEN KE-MIN |
Regulation Number | 882.5890
|
Classification Product Code |
|
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
|
|
|