FDA 510(k) Application Details - K170872

Device Classification Name	Gas-Machine, Anesthesia   More FDA Info for this Device
510(K) Number	K170872
Device Name	Gas-Machine, Anesthesia
Applicant	Datex-Ohmeda, Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707-7550 US Other 510(k) Applications for this Company
Contact	Michelle Huettner Other 510(k) Applications for this Contact
Regulation Number	868.5160   More FDA Info for this Regulation Number
Classification Product Code	BSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2017
Decision Date	08/15/2017
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