Device Classification Name |
Oximeter
|
510(k) Number |
K092652 |
Device Name |
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
BAILANGUYAN BLDG B 1127-1128 |
FUXING RD, A36 |
BEIJING,
CN
100039
|
|
Applicant Contact |
LEI CHEN |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
BAILANGUYAN BLDG B 1127-1128 |
FUXING RD, A36 |
BEIJING,
CN
100039
|
|
Correspondent Contact |
LEI CHEN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/28/2009 |
Decision Date | 01/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|