FDA 510(k) Application Details - K043148

Device Classification Name Filter, Bacterial, Breathing-Circuit

  More FDA Info for this Device
510(K) Number K043148
Device Name Filter, Bacterial, Breathing-Circuit
Applicant ALLIANCE TECH MEDICAL, INC.
611 SOUTH SCHOOLHOUSE CREEK RD
GRANTS PASS, OR 97526 US
Other 510(k) Applications for this Company
Contact KEITH LOWREY
Other 510(k) Applications for this Contact
Regulation Number 868.5260

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

  More FDA Info for this Product Code
Date Received 11/15/2004
Decision Date 12/13/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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