Device Classification Name |
oximeter
|
510(k) Number |
K142687 |
Device Name |
Pulse Oximeter |
Applicant |
Shanghai Berry Electronic Tech Co., Ltd |
Unit C, 1st Floor, 7th Building, No. 1188 Lianhang Road |
shanghai,
CN
|
|
Applicant Contact |
xuezhi yin |
Correspondent |
Beijing Believe Tech. Service Co., Ltd. |
1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., |
beijing,
CN
|
|
Correspondent Contact |
ray wang |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 04/13/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|