FDA 510(k) Application Details - K040581

Device Classification Name Oximeter

  More FDA Info for this Device
510(K) Number K040581
Device Name Oximeter
Applicant VITEL NET
8201 GREENSBORO DR.
SUITE 820
MCLEAN, VA 22102 US
Other 510(k) Applications for this Company
Contact ALLEN IZADPANAH
Other 510(k) Applications for this Contact
Regulation Number 870.2700

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

  More FDA Info for this Product Code
Date Received 03/04/2004
Decision Date 05/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
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