Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K120671 |
Device Name |
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) |
Applicant |
COTRONIC TECHNOLOGY LIMITED |
WEST OF ZHOU SHI RD |
XI XIANG ST, BAO AN ZONE |
SHEN ZHEN, GUANG DONG,
CN
518126
|
|
Applicant Contact |
TANI MOK |
Correspondent |
COTRONIC TECHNOLOGY LIMITED |
WEST OF ZHOU SHI RD |
XI XIANG ST, BAO AN ZONE |
SHEN ZHEN, GUANG DONG,
CN
518126
|
|
Correspondent Contact |
TANI MOK |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 03/05/2012 |
Decision Date | 05/17/2013 |
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
|
|
|