FDA 510(k) Application Details - K983981

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K983981
Device Name	Ventilator, Continuous, Facility Use
Applicant	BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. PALM SPRINGS, CA 92262 US Other 510(k) Applications for this Company
Contact	DARRYL SHELBY 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	11/09/1998
Decision Date	11/20/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review