FDA 510(k) Application Details - K972657

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K972657
Device Name	Nebulizer (Direct Patient Interface)
Applicant	TEXAS MEDICAL INDUSTRIES, INC. 1409 INDUSTRIAL PARK ROYSE CITY, TX 75189 US Other 510(k) Applications for this Company
Contact	STEVE HARLOW Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/1997
Decision Date	02/02/1998
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