FDA 510(k) Application Details - K040507

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K040507
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	TAGA MEDICAL TECHNOLOGIES, INC. 34675 VOKES DR. SUITE 105 EASTLAKE, OH 44095 US Other 510(k) Applications for this Company
Contact	GARY AUSTIN Other 510(k) Applications for this Contact
Regulation Number	868.5450   More FDA Info for this Regulation Number
Classification Product Code	BTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2004
Decision Date	03/04/2004
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