Device Classification Name |
oximeter
|
510(k) Number |
K160268 |
Device Name |
Fingertip Pulse Oximeter MD300CG11/MD300CG51 |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
NO.9 SHUANGYUAN ROAD |
BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT |
BEIJING,
CN
100041
|
|
Applicant Contact |
LEI CHEN |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
NO.9 SHUANGYUAN ROAD |
BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT |
BEIJING,
CN
100041
|
|
Correspondent Contact |
LEI CHEN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/02/2016 |
Decision Date | 10/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|