FDA 510(k) Application Details - K060675

Device Classification Name Oximeter

  More FDA Info for this Device
510(K) Number K060675
Device Name Oximeter
Applicant ENVITEC-WISMAR GMBH
S65 W35739 PIPER RD
EAGLE, WI 53119 US
Other 510(k) Applications for this Company
Contact STEPHEN GORSKI
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 03/14/2006
Decision Date 07/17/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
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