FDA 510(k) Application Details - K041823

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K041823
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK TAICHUNG 407 TW Other 510(k) Applications for this Company
Contact	STEVE CHAO Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2004
Decision Date	05/10/2005
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