Device Classification Name |
oximeter
|
510(k) Number |
K092620 |
Device Name |
MD300C318 FINGERTIP PULSE OXIMETER |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
NORTH BUILDING 3F, NO.9 |
SHUANGYUAN RD., BADACHU HITECH |
SHIJINGSHAN DISTRICT, BEIJING,
CN
100041
|
|
Applicant Contact |
YAJING LI |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
NORTH BUILDING 3F, NO.9 |
SHUANGYUAN RD., BADACHU HITECH |
SHIJINGSHAN DISTRICT, BEIJING,
CN
100041
|
|
Correspondent Contact |
YAJING LI |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/26/2009 |
Decision Date | 12/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|