Device Classification Name |
Oximeter
|
510(k) Number |
K191417 |
Device Name |
Belun Ring |
Applicant |
Belun Technology Company Limited |
Rm531B, floor 5, Core Building 2, 1 Science Park West Avenue |
HK Science Park |
Sha Tin,
HK
|
|
Applicant Contact |
Leung Lap Wai Lydia |
Correspondent |
Belun Technology Company Limited |
Rm531B, floor 5, Core Building 2, 1 Science Park West Avenue |
HK Science Park |
Sha Tin,
HK
|
|
Correspondent Contact |
Leung Lap Wai Lydia |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/28/2019 |
Decision Date | 10/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|