Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K081788 |
Device Name |
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 |
Applicant |
INNOCHIPS TECHNOLOGY CO., LTD. |
49 CANDLEWOOD WAY |
BUENA PARK,
CA
90621
|
|
Applicant Contact |
BRANDON CHOI |
Correspondent |
INNOCHIPS TECHNOLOGY CO., LTD. |
49 CANDLEWOOD WAY |
BUENA PARK,
CA
90621
|
|
Correspondent Contact |
BRANDON CHOI |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 06/24/2008 |
Decision Date | 12/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|