FDA 510(k) Application Details - K040194

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K040194
Device Name	Ventilatory Effort Recorder
Applicant	COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE EL PASO, TX 79912 US Other 510(k) Applications for this Company
Contact	ELVIRA GARCIA Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2004
Decision Date	04/23/2004
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