FDA 510(k) Application Details - K982215

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K982215
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	MEDICAL MARKETING CONCEPTS P.O. BOX 4341 CROFTON, MD 21114-4341 US Other 510(k) Applications for this Company
Contact	E J SMITH 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	06/23/1998
Decision Date	09/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review