FDA 510(k) Application Details - K023820

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

  More FDA Info for this Device
510(K) Number K023820
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant BREGAS AB
ULVSUNDAVAGEN 178B
BROMMA SE-16867 SE
Other 510(k) Applications for this Company
Contact PAUL KRILL
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 11/15/2002
Decision Date 05/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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