Device Classification Name |
oximeter
|
510(k) Number |
K072825 |
Device Name |
FINGERTIP PULSE OXIMETER, MODEL MD300I |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
SUITE 8D, ZHONGXIN ZHONGSHAN |
NO19, LN999, ZHONG SHAN NAN ER |
SHANGHAI,
CN
200030
|
|
Applicant Contact |
Diana Hong |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
SUITE 8D, ZHONGXIN ZHONGSHAN |
NO19, LN999, ZHONG SHAN NAN ER |
SHANGHAI,
CN
200030
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/02/2007 |
Decision Date | 01/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|