FDA 510(k) Application Details - K093154

Device Classification Name	Monitor, Carbon-Dioxide, Cutaneous   More FDA Info for this Device
510(K) Number	K093154
Device Name	Monitor, Carbon-Dioxide, Cutaneous
Applicant	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	JANA HELLMAN Other 510(k) Applications for this Contact
Regulation Number	868.2480   More FDA Info for this Regulation Number
Classification Product Code	LKD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/06/2009
Decision Date	02/05/2010
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