Device Classification Name |
Oximeter
|
510(k) Number |
K142888 |
Device Name |
Fingertip Pulse Oximeter |
Applicant |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
No.9 Shuangyuan Road, Badachu Hi-tech Zone, |
Shijingshan District |
BEIJING,
CN
100041
|
|
Applicant Contact |
Lei Chen |
Correspondent |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY 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 | 10/02/2014 |
Decision Date | 02/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|