Device Classification Name |
Oximeter
|
510(k) Number |
K190869 |
Device Name |
Pulse Oximeter |
Applicant |
Shenzhen Aeon Technology Co., Ltd. |
RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong |
No.133 of Yiyuan road, Nantou Street, Nanshan District |
Shenzhen,
CN
518052
|
|
Applicant Contact |
Xie Hua |
Correspondent |
Chonconn Medical Device Consulting Co., Ltd. |
No. A415, Block A, NanShan Medical devices Industrial Park |
Nanshan District |
Shenzhen,
CN
518067
|
|
Correspondent Contact |
Kevin Wang |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/03/2019 |
Decision Date | 09/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|