FDA 510(k) Application Details - K040366

Device Classification Name Valve, Non-Rebreathing

  More FDA Info for this Device
510(K) Number K040366
Device Name Valve, Non-Rebreathing
Applicant FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI NZ
Other 510(k) Applications for this Company
Contact ROBERT PETRY
Other 510(k) Applications for this Contact
Regulation Number 868.5870

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

  More FDA Info for this Product Code
Date Received 02/13/2004
Decision Date 03/04/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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