FDA 510(k) Application Details - K082655

Device Classification Name	Analyzer, Gas, Oxygen, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K082655
Device Name	Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant	ENVITEC-WISMAR GMBH S65 W35739 PIPER ROAD EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN GORSKI Other 510(k) Applications for this Contact
Regulation Number	868.1720   More FDA Info for this Regulation Number
Classification Product Code	CCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2008
Decision Date	11/25/2008
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