FDA 510(k) Application Details - K980384

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K980384
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. TEWKSBURY, MA 01876 US Other 510(k) Applications for this Company
Contact	JOEL C KENT Other 510(k) Applications for this Contact
Regulation Number	868.1400   More FDA Info for this Regulation Number
Classification Product Code	CCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/1998
Decision Date	05/01/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review