FDA 510(k) Application Details - K992670

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K992670
Device Name	Ventilator, Continuous, Facility Use
Applicant	INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. BETHEL PARK, PA 15102 US Other 510(k) Applications for this Company
Contact	TRICIA WOOD 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	06/21/1999
Decision Date	09/17/1999
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