Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K100488 |
Device Name |
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 |
Applicant |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ESTAE XILIXIAOBAIMANG |
NANSHAN DISTRICT, SHENZHEN,
CN
518108
|
|
Applicant Contact |
ZHIGANG ZHAO |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 02/19/2010 |
Decision Date | 07/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|