Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K122221 |
Device Name |
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER |
Applicant |
TaiDoc Technology Corporation |
3F,5F, No.127, Wugong 2nd Rd. |
Wugu District |
New Taipei City,
TW
24888
|
|
Applicant Contact |
PINJUNG CHEN |
Correspondent |
TaiDoc Technology Corporation |
3F,5F, No.127, Wugong 2nd Rd. |
Wugu District |
New Taipei City,
TW
24888
|
|
Correspondent Contact |
PINJUNG CHEN |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 03/29/2013 |
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
|
|
|