Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K041056 |
Device Name |
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 |
Applicant |
MESURE TECHNOLOGY CO.,LTD. |
7F, 88, SEC. 1, KWANG FU ROAD |
SAN CHUNG CITY |
TAIPEI HSIEN,
TW
R.O.C.
|
|
Applicant Contact |
ROGER LU |
Correspondent |
MESURE TECHNOLOGY CO.,LTD. |
7F, 88, SEC. 1, KWANG FU ROAD |
SAN CHUNG CITY |
TAIPEI HSIEN,
TW
R.O.C.
|
|
Correspondent Contact |
ROGER LU |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 04/23/2004 |
Decision Date | 05/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|