FDA 510(k) Application Details - K970991

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K970991
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	PROMEDIC, INC. 6329 WEST WATERVIEW CT. MCCORDSVILLE, IN 46055-9501 US Other 510(k) Applications for this Company
Contact	PAUL E DRYDEN 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	03/19/1997
Decision Date	06/16/1997
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review