FDA 510(k) Application Details - K101690

Device Classification Name	Monitor, Carbon-Dioxide, Cutaneous   More FDA Info for this Device
510(K) Number	K101690
Device Name	Monitor, Carbon-Dioxide, Cutaneous
Applicant	SENTEC AG S65 W35739 PIPER ROAD EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN H GORSKI 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	06/16/2010
Decision Date	12/03/2010
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