Device Classification Name |
Oximeter
|
510(k) Number |
K202173 |
Device Name |
Pulse Oximeter |
Applicant |
Shenzhen AOJ Medical Technology Co., Ltd. |
601, 6th floor, B2 Building, An'le Industrial Park |
#172 Hangcheng Avenue |
Shenzhen,
CN
518126
|
|
Applicant Contact |
Wendy Lin |
Correspondent |
Shenzhen AOJ Medical Technology Co., Ltd. |
601, 6th floor, B2 Building, An'le Industrial Park |
#172 Hangcheng Avenue |
Shenzhen,
CN
518126
|
|
Correspondent Contact |
Wendy Lin |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/03/2020 |
Decision Date | 12/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|