Device Classification Name |
oximeter
|
510(k) Number |
K191430 |
Device Name |
Pulse Oximeter |
Applicant |
Shenzhen Yimi Life-Technology Co.,Ltd. |
305 Tengbo Industrial Park, Changshangjiang Street, |
Longbei Village, Pingshan |
Shenzhen,
CN
518118
|
|
Applicant Contact |
Shande Peng |
Correspondent |
Shenzhen Yimi Life-Technology Co.,Ltd. |
305 Tengbo Industrial Park, Changshangjiang Street, |
Longbei Village, Pingshan |
Shenzhen,
CN
518118
|
|
Correspondent Contact |
Shande Peng |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/29/2019 |
Decision Date | 10/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|