FDA 510(k) Application Details - K010925

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K010925
Device Name	Ventilator, Continuous, Facility Use
Applicant	SIEMENS ELEMA AB MEDICAL SOLUTIONS 186 WOOD AVENUE SOUTH ISELIN, NJ 08830-2770 US Other 510(k) Applications for this Company
Contact	DIANE WURZBURGER Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2001
Decision Date	12/18/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review