FDA 510(k) Application Details - K970839

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K970839
Device Name	Ventilator, Continuous, Facility Use
Applicant	SIEMENS ELEMA AB RONTGENVAGEN 2 S-17195 SOLNA SE Other 510(k) Applications for this Company
Contact	ANN-CHRISTINE JONSSON 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	03/07/1997
Decision Date	10/14/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review