FDA 510(k) Application Details - K002846

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K002846
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	HEADSTAR MEDICAL PRODUCTS CO., LTD NO 23, LANE 431, HWA CHEN RD HSIN-CHUANG CITY TAIPEI HSIEN ROC 242 CN Other 510(k) Applications for this Company
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	09/12/2000
Decision Date	06/06/2001
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