Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K010224 |
Device Name |
NPAC MULTI-USE THERMOMETER, MODEL TD400 |
Applicant |
NORM PACIFIC AUTOMATION CORP. |
3F, NO. 31, HU-PIN ROAD #1 |
SBIP |
HSIN-CHU,
TW
|
|
Applicant Contact |
CHI-CHU WU CHEN |
Correspondent |
NORM PACIFIC AUTOMATION CORP. |
3F, NO. 31, HU-PIN ROAD #1 |
SBIP |
HSIN-CHU,
TW
|
|
Correspondent Contact |
CHI-CHU WU CHEN |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 01/24/2001 |
Decision Date | 03/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|