Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K031907 |
Device Name |
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 |
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 | 06/20/2003 |
Decision Date | 08/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|