Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K063291 |
Device Name |
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 |
Applicant |
CHOICE SMART HEALTH CARE CO. LTD. |
2108 CIRO'S PLAZA |
388 WEST NANJING ROAD |
SHANGHAI,
CN
200003
|
|
Applicant Contact |
JANICE MA |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 11/01/2006 |
Decision Date | 11/21/2006 |
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
|
|
|