Device Classification Name |
Oximeter
|
510(k) Number |
K082641 |
Device Name |
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
Applicant |
CONTEC MEDICAL SYSTEM CO., LTD. |
SUITE 8D , ZHONGXIN ZHONGSHAN |
MANSION, NO. 19, LANE 999, |
ZHONG SHAN, SHANGHAI,
CN
20030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
CONTEC MEDICAL SYSTEM CO., LTD. |
SUITE 8D , ZHONGXIN ZHONGSHAN |
MANSION, NO. 19, LANE 999, |
ZHONG SHAN, SHANGHAI,
CN
20030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/11/2008 |
Decision Date | 11/10/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|