FDA 510(k) Application Details - K192446

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

  More FDA Info for this Device
510(K) Number K192446
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant Beijing Kingst Commercial & Trade Co.,Ltd.
6th Floor of No.2-7,Road Beibinhe
Xibianmen
Beijing 100053 CN
Other 510(k) Applications for this Company
Contact Judong Gao
Other 510(k) Applications for this Contact
Regulation Number 868.1400

  More FDA Info for this Regulation Number
Classification Product Code CCK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/06/2019
Decision Date 05/21/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact