Device Classification Name |
Oximeter
|
510(k) Number |
K211400 |
Device Name |
Pulse Oximeter |
Applicant |
Beijing Choice Electronic Technology Co., Ltd. |
No.9 Shuangyuan Road, Badachu Hi-tech Zone, |
Shijingshan District |
Beijing,
CN
100041
|
|
Applicant Contact |
Haiying Zhao |
Correspondent |
Beijing Choice Electronic Technology Co., Ltd. |
No.9 Shuangyuan Road, Badachu Hi-tech Zone, |
Shijingshan District |
Beijing,
CN
100041
|
|
Correspondent Contact |
Haiying Zhao |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/05/2021 |
Decision Date | 02/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|