FDA 510(k) Application Details - K023565

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

  More FDA Info for this Device
510(K) Number K023565
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant CARADYNE, LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE, IN 46055 US
Other 510(k) Applications for this Company
Contact PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number 868.1720

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

  More FDA Info for this Product Code
Date Received 10/23/2002
Decision Date 03/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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