The following data is part of a premarket notification filed by Beijing Kingst Commercial & Trade Co.,ltd. with the FDA for Co2 Mainstream Module.
Device ID | K192446 |
510k Number | K192446 |
Device Name: | CO2 Mainstream Module |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | Beijing Kingst Commercial & Trade Co.,Ltd. 6th Floor Of No.2-7,Road Beibinhe Xibianmen Beijing, CN 100053 |
Contact | Judong Gao |
Correspondent | Charlie Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-06 |
Decision Date | 2020-05-21 |