Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K192488 |
Device Name |
CO2 Sidestream Module |
Applicant |
Beijing Kingst Commercial & Trade Co.,Ltd. |
6th Floor of No.2-7,Road Beibinhe |
Xibianmen |
Beijing,
CN
100053
|
|
Applicant Contact |
Judong Gao |
Correspondent |
IRC |
2950 E Lindrick Drive |
Chandler,
AZ
85249
|
|
Correspondent Contact |
Charlie Mack |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 09/11/2019 |
Decision Date | 05/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|