510(k) K192446
K192446 is an FDA 510(k) premarket notification submitted by Beijing Kingst Commercial & Trade Co., Ltd. for the device "CO2 Mainstream Module". The FDA issued a decision of Substantially Equivalent on May 21, 2020. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Beijing Kingst Commercial & Trade Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2020
- Date Received
- Sep 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type
- 510(k)