FDA 510(k) Application Details - K010318

Device Classification Name	Analyzer, Gas, Oxygen, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K010318
Device Name	Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant	PENLON LTD. RADLEY ROAD ABINGDON OXFORDSHIRE OX14 3PH GB Other 510(k) Applications for this Company
Contact	ANTHONY PARSONS 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	02/02/2001
Decision Date	07/23/2001
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