FDA 510(k) Application Details - K842795

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

  More FDA Info for this Device
510(K) Number K842795
Device Name Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant NOVA-VENTRX

, US
Other 510(k) Applications for this Company
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 07/17/1984
Decision Date 10/04/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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