FDA 510(k) Application Details - K002454

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K002454
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE ENGLEWOOD, CO US Other 510(k) Applications for this Company
Contact	THOMAS W DIELMANN 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	08/10/2000
Decision Date	03/07/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review