Device Classification Name |
Oximeter
|
510(k) Number |
K202776 |
Device Name |
Fingertip pulse oximeter |
Applicant |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
North side of floor 3, BLD 9 BaiWangxin High-Tech |
Industrial Park, Songbai Roa |
Shenzhen,
CN
518055
|
|
Applicant Contact |
Aaron Lin |
Correspondent |
FDA Regulatory and Quality Systems Consultant |
31853 Cedar Road |
Mayfield Heights,
OH
44124 -4445
|
|
Correspondent Contact |
Arthur Goddard |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/21/2020 |
Decision Date | 03/01/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|