Device Classification Name |
Oximeter
|
510(k) Number |
K192343 |
Device Name |
Patient Monitor |
Applicant |
Shenzhen Creative Industry Co., Ltd. |
Floor 5, BLD 9 Baiwangxin High-Tech Industrial Park |
Songbai Road, Xili Street |
Shenzhen,
CN
518110
|
|
Applicant Contact |
Jia Wang |
Correspondent |
IRC |
2950 E Lindrick Drive |
Chandler,
AZ
85249
|
|
Correspondent Contact |
Charlie Mack |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/28/2019 |
Decision Date | 12/31/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|