FDA 510(k) Application Details - K111570

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K111570
Device Name	Nebulizer (Direct Patient Interface)
Applicant	THAYER MEDICAL CORPORATION 4575 SOUTH PALO VERDE Road SUITE 337 TUCSON, AZ 85714-1961 US Other 510(k) Applications for this Company
Contact	ERIKA S STRICKLAND 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	06/06/2011
Decision Date	09/29/2011
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