Device Classification Name |
oximeter
|
510(k) Number |
K230277 |
Device Name |
Pulse Oximeter(Model OHT60,OXH78) |
Applicant |
Cofoe Medical Technology Co., Ltd. |
No.87, Section 1, East Huanbao Road, Yuhua District |
Changsha,
CN
410000
|
|
Applicant Contact |
Yang Cui |
Correspondent |
Shanghai Truthful Information Technology Co., Ltd. |
RM.1801,No.161,East Lujiazui Rd.,Pudong |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Boyle Wang |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/01/2023 |
Decision Date | 01/04/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|