FDA 510(k) Application Details - K963848

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K963848
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	OWENS-BRIGAM MEDICAL CO. 65 HANES RD. NEWLAND, NC 28657 US Other 510(k) Applications for this Company
Contact	BILL BROOKS Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/1996
Decision Date	07/07/1997
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