FDA 510(k) Application Details - K991484

Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)

  More FDA Info for this Device
510(K) Number K991484
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
Other 510(k) Applications for this Company
Contact SHARON ROBBINS
Other 510(k) Applications for this Contact
Regulation Number 868.5450

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

  More FDA Info for this Product Code
Date Received 04/28/1999
Decision Date 05/13/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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